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PubMedDate not supplied

Diagnosis of temporomandibular disorders according to RDC/TMD axis I findings, a multicenter Italian study.

AIM: The aim of the present study was to evaluate the prevalence of the different Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I types of temporomandibular disorders (TMD) in a population of subjects seeking for TMD treatment at 2 University Departments in Italy and to compare it with data from similar studies in the literature, in order to assess the usefulness of the RDC/TMD classification system as a tool for epidemiological data gathering and multicenter and cross-cultural comparison. METHODS: A total of 210 consecutive patients seeking for TMD treatment at the Section of Prosthetic Dentistry, Department of Neuroscience, University of Pisa, Italy, and 109 consecutive patients seeking treatment at the Section of Prosthetic Dentistry and Temporo-mandibular Disorders, University of Pavia, Italy, were assessed using RDC/TMD. RESULTS: Only 181 of the patients referring to the University of Pisa and 104 of those referring to the University of Pavia satisfied the criteria for inclusion. Findings from the 2 study populations were very similar. Mean age of the patients was 40 years, with a female:male ratio of 3.5:1 (222 females, 77.9%; 63 males, 22.1%). The prevalence of RDC/TMD Axis I diagnoses was 50.2% (143/285) for Group I disorders (muscle disorders), 38.6% (110/285) for Group II disorders (disc displacement), and 50.2% (143/285) for Group III disorders (arthralgia, osteoarthritis, osteoarthrosis). CONCLUSION: Results from the present investigation have confirmed the usefulness of the RDC/TMD classification system for research purposes and for data gathering in cross-cultural and multicenter comparisons.

Adult↗
PubMed2004

Encapsulating peritoneal sclerosis in Japan: a prospective, controlled, multicenter study.

BACKGROUND: Encapsulating peritoneal sclerosis (EPS) is recognized as a rare but serious complication of peritoneal dialysis (PD). The aim of this study was to determine the incidence, clinical features, and mortality rate of EPS. METHODS: The authors requested the registration of all PD patients in facilities across Japan where more than 10 patients were treated with PD in this prospective multicenter study. During the 4-year study, the incidence of EPS was observed in the enrolled patients. RESULTS: A total of 1,958 patients who were treated with PD in 57 facilities were followed up from April 1999 through March 2003. EPS occurred in 48 patients, corresponding to an overall incidence of 2.5%. In 33 of the 48 (68.8%) patients, EPS was found after discontinuation of PD. The incidence (and mortality rate) of EPS was 0%, 0.7% (0%), 2.1% (8.3%), 5.9% (28.6%), 5.8% (61.5%), and 17.2% (100%) in patients who had undergone PD for 3, 5, 8, 10, 15, and more than 15 years, respectively. The recovery ratio with total parenteral nutrition, corticosteroids and surgical treatment were 0%, 38.5%, and 58.3%, respectively. Eighteen patients (37.5%) died, 22 (45.8%) recovered, and the status of the other 8 (16.7%) remained unchanged. CONCLUSION: The results of this prospective multicenter study showed that the incidence of EPS was 2.5% within a 4-year observation period and that two thirds of the cases were diagnosed after discontinuation of PD. Because of the current progress in diagnostic technology and therapeutic methodology, it appears that PD can be continued successfully with an acceptable, low risk for EPS for at least 8 years, whereas stricter caution is required for patients receiving PD for longer periods.

Adult↗
PubMed2004

Legg-Calve-Perthes disease. Part II: Prospective multicenter study of the effect of treatment on outcome.

BACKGROUND: The treatment of Legg-Calve-Perthes disease has been based on uncontrolled retrospective studies with relatively small numbers of patients. This large, controlled, prospective, multicenter study was designed to determine the effect of treatment and other risk factors on the outcome in patients with this disorder. METHODS: We enrolled 438 patients with 451 affected hips in a prospective multicenter study in which each investigator applied the same treatment method to each of his or her patients. The five treatment groups consisted of no treatment, brace treatment, range-of-motion exercises, femoral osteotomy, and innominate osteotomy. All patients were between 6.0 and 12.0 years of age at the onset of the disease, and none had had prior treatment. Three hundred and forty-five hips in 337 patients were available for follow-up at skeletal maturity. All hips were classified with the modified lateral pillar classification and the system of Stulberg et al. RESULTS: There were no differences in outcome among the hips with no treatment, those treated with bracing, and those treated with range-of-motion therapy. There were also no differences between the hips treated with a femoral varus osteotomy and those treated with an innominate osteotomy. Treatment did not have a significant effect on children who had a chronologic age of 8.0 years or less or a skeletal age of 6.0 years or less at the onset of the disease. In the lateral pillar B group and B/C border group, the outcomes of surgical treatment were significantly better than those of nonoperative treatment in children over the age of 8.0 years at the onset of the disease (p < or = 0.05). Patients who were 8.0 years old or less at the onset of the disease in lateral pillar group B did equally well with nonoperative and operative treatment. Hips in lateral pillar group C had the least favorable outcomes, with no differences between the operative and nonoperative groups. The lateral pillar classification (p < 0.0001) and the age at the onset of the disease (p = 0.0001) were both strong prognostic factors. Female patients did significantly worse than male patients if they were over the age of 8.0 years at the onset of the disease (p = 0.004). CONCLUSIONS: The lateral pillar classification and age at the time of onset of the disease strongly correlate with outcome in patients with Legg-Calve-Perthes disease. Patients who are over the age of 8.0 years at the time of onset and have a hip in the lateral pillar B group or B/C border group have a better outcome with surgical treatment than they do with nonoperative treatment. Group-B hips in children who are less than 8.0 years of age at the time of onset have very favorable outcomes unrelated to treatment, whereas group-C hips in children of all ages frequently have poor outcomes, which also appear to be unrelated to treatment.

Age of Onset↗
PubMed1992

Quality control of surgical technique in a multicenter, prospective, randomized, controlled study on the surgical treatment of gastric cancer.

To evaluate the effect of lymph node dissection on gastric cancer patients operated upon with curative intent, we are carrying out a multicenter, prospective, randomized, controlled study in the Netherlands. The trial compares conventional gastrectomy to gastrectomy with extended lymph node dissection. In the first four months, a Japanese supervisor attended all the extended surgery and instructed many Dutch surgeons, including the eight consulting surgeons; since then, all extended gastrectomies have been attended by one of the consulting surgeons. The study coordinator attended all conventional cases. This assured that the quality of the extended surgery was as good as the Japanese standard, of which excellent results have been reported. To achieve this quality control, randomization before surgery was obligatory for practical reasons. Curability assessment at laparotomy, however, is done quite objectively with histological proof, except for the judgement of irresectability. Although this has resulted in many non-curative cases being randomized but subsequently not given the allocated surgery, the sample size should be sufficient to allow analysis according to randomization or the initial "intention to treat." This is the first protocol for a multicenter trial in surgical oncology to have such excellent surgical quality control and to assure a quality as high as that in the original report with uniformity in the level of technique. In studies comparing surgical techniques, it is vital that attention should be given to surgical quality control, otherwise survival rates may show little improvement and fail to make any impact on surgical practice.

Adenocarcinoma↗
PubMed2005

"Method-specific" stability of serum C-peptide in a multicenter clinical study.

A Central laboratory that participates in multicenter clinical studies must consider and study the parameters that condition the in vitro stability of the analytes. We evaluated the effect of temperature on serum C-peptide storage during transport from clinical research centers to the Central laboratory. In particular, the stability for storage lengths from 0 to 24-48 hours at temperatures of between -20 degrees C and +37 degrees C were studied: the C-peptide assay was performed by means of a chemiluminescence and a RIA method. The tests confirmed that sample freezing is the gold standard for accurate determination of serum C-peptide and that storage at 37 degrees C may decrease the analyte levels. Instead, C-peptide stability at 2-8 degrees C appeared "method-specific"; while no apparent alteration was obtained with the chemiluminescence method up to 24 hours of storage, the RIA showed an early slight increase in C-peptide that is proportionate to storage time. Our work highlights that before starting up a multicenter clinical study it is always necessary to optimize and standardize biological sample storage and transport conditions to guarantee a high quality sample for analysis. Beyond this, it is even very useful to check the reliability of technical and instrumental resources that the Central laboratory will use during the study because molecular alterations of the analytes due to variable storage conditions can cause misleading results.

Adult↗
PubMed2005

A multicenter study of 705 ruptured intracranial aneurysms treated with Guglielmi detachable coils.

BACKGROUND AND PURPOSE: The long-term durability of Guglielmi detachable coil (GDC) embolization of cerebral aneurysms is still unknown. The purpose of this study was to evaluate the stability of anatomic occlusion of aneurysms treated with GDCs and assess the rate of recanalization and re-treatment. METHODS: A multicenter study involving 650 patients with 705 ruptured aneurysms treated with GDCs between January 1998 to May 2003 was conducted. During this period, 63% of ruptured aneurysms were treated by the endovascular technique. The morbidity and mortality associated with this technique, procedural feasibility, acute angiographic occlusion results, and long-term angiographic follow-up were assessed. RESULTS: Overall technical feasibility of GDC treatment was 96.9%. Upon admission, 25% of patients were Hunt and Hess grade IV or V. Acute angiographic results in 683 aneurysms demonstrated total occlusion in 496 cases (72.6%), subtotal occlusion in 171 cases (25.%), and incomplete occlusion in 16 cases (2.4%). All patients were controlled by angiography and MR imaging at 3 months, 1 year, and subsequent yearly examinations post-treatment. A second treatment was performed in 27 cases (recanalization, 4.7%). Long-term follow-up angiograms (mean, 36 months) were obtained in 571 aneurysms (95%). Of them, 422 aneurysms (73.9%) demonstrated complete occlusion, 148 aneurysms (25.9%) demonstrated subtotal occlusion, and only 1 aneurysm was incompletely occluded. Overall mortality was 11.4% for all patients, with procedural mortality evaluated at 1.4%. Overall morbidity was calculated at 8.6%. Only one rebleeding occurred in our study, with a second procedure performed without vital consequences for the patient. CONCLUSION: Our multicenter study confirms the stability of aneurysm embolization with GDC, with only 4.7% of aneurysms requiring re-treatment.

Adolescent↗
PubMed1992

Accuracy and precision of computer-aided sperm analysis in multicenter studies.

STUDY OBJECTIVES: To develop methods of instrument calibration and standardization that enable the use of computer-aided sperm analysis (CASA) technology in multicenter studies of sperm motility. SETTING: Clinical semen evaluation for the andrology laboratory and in vitro fertilization programs. PATIENTS: Semen specimens were selected from the videotape archives of the University of California at Davis Andrology Laboratory and used to produce a videotape reference standard for CASA instrument testing and calibration. Four identical CASA instruments, two each at two sites, were used to analyze the videotape. Machine accuracy was verified by manual analysis of the videotape. RESULTS: The coefficient of variation (CV) for repeated measures was between 1% and 8% for each variable on all CASA instruments. Mean values for CASA parameters varied as a function of the digitization threshold. A minimum CV was obtained at a particular threshold setting, suggesting an optimum for each machine. Because of high within-machine precision, slight differences in mean values between machines were statistically significant for some variables and some specimens; such differences are probably not biologically significant. CONCLUSION: Multicenter standardization of CASA instrumentation is possible, but threshold settings are one source of variation that must be controlled using CVs or another means of objective calibration. One method is to adjust the threshold of each instrument until the count obtained by CASA equals the count obtained by the manual method used to determine the dilution requirements for neat semen.

Computers↗
PubMed1991

[Multicenter study with a large number of patients for the validation of pharmacokinetic and clinical findings from controlled studies with small patient cohorts].

In 94 surgeries a total of 682 patients were included into a multicenter study. Serum theophylline concentrations were monitored in patients with obstructive pulmonary diseases, that were treated with theophylline dosages as recommended in the Euphylong professional information or as adjusted after a theophylline serum level control. Peak-flow rates and theophylline tolerance as stated by the patients were also monitored and documented. 72% of the patients already received theophylline in the past. The increase of the mean daily dosage of theophylline to 750 mg administered as a single dose in the evening raised the concentration of serum theophylline in average from 8.7 +/- 5.0 mg/l to 12.2 +/- 4.1 mg/l. No increase of the portion of patients with serum concentrations above 20 mg/l was observed. The patients additional bronchodilatory medication remained unchanged during the study. As a consequence of the improved theophylline medication morning and evening peak-flow rates increased in average from 272 +/- 99 l/min to 315 +/- 109 l/min and 278 +/- 101 l/min to 318 +/- 107 l/min, respectively. After a temporary increase during the first week of treatment the frequency of side effects decreased below the one stated at the starting point of the study. Out of 106 patients, that did not finish the study, 44 (= 6.5%) dropped out because of side effects. The overall assessment of effectiveness and tolerance of Euphylong by physicians and patients was good to very good. Herein the single dosage per day was well accepted by most of the patients. The results of the presented multicenter study with Euphylong therefore confirm the pharmacokinetic and clinical data gained from single center studies with small patient numbers hitherto.

Adolescent↗
PubMed1991

Italian Multicenter Study on Very Low Birth Weight Babies.

The Italian Multicenter Study on Very Low Birth Weight babies (IMS-VLBW) is the first collaborative investigation performed in Italy on the health status of newborns weighing less than 1500 g at birth. Eight Neonatal Intensive Care Units (NICUs) participated in the study: Cagliari, Napoli, Padova, Palermo, Roma, Sassari, Trieste, Udine. Data were analyzed in the Laboratorio di Epidemiologia e Biostatistica of the Istituto Superiore di Sanità. The objectives of the study were established in the following: a) to collect accurate descriptive data on neonatal morbidity, mortality and long term outcome of VLBW babies admitted to NICUs; b) to analyze the risk factors of unfavourable outcome (death or handicap) and to analyze, with respect to outcome, the relationships between risk factors, neonatal diseases and therapeutical procedures; c) to test the feasibility of a multicenter follow-up programme based on the use in all participating Centers of the same diagnostic criteria (the results of follow-up will be presented in a forthcoming paper). In the years 1987 and 1988, 634 newborns weighing 500-1499 g at birth were enrolled in the study. In-hospital mortality for the whole group was 33.1% (65.1% in the 500-999 g birth weight class and 19.2% in the 1000-1499 g class). Mortality was not different for inborn vs outborn babies. A high incidence of unfavourable perinatal conditions was observed in these babies, namely birth asphyxia, sub-optimal care during transport, poor clinical conditions on arrival to the NICU. Neonatal diseases, like respiratory distress syndrome and peri-intra ventricular hemorrhage were also frequent and severe. A logistic regression analysis of pre-admission risk factors of in-hospital death identified eight statistically significant variables: birth weight; gestational age; sex; antenatal steroid stimulation of lung maturity; first minute Apgar score; absence of spontaneous respiration, body temperature and pH on arrival to the NICU. Using the equation derived from the logistic regression analysis a theoretical mortality rate, predicted on the basis of the local incidence of pre-admission risk factors, was calculated for each Center. In no case the predicted mortality was statistically different from the observed one, suggesting that in our study differences in observed mortality rates from one Center to another are largely influenced by pre-admission risk factors.

Apgar Score↗
PubMed1991

[Combined uni- and multicenter double-blind studies in hypertensive patients. Comparison of blood pressure measurements].

In a double-blind study to investigate the antihypertensive effect of a fixed triple combination with 0.05 mg reserpine, 2.5 mg clopamide and 0.4 mg dihydroergocristine in comparison to a fixed double combination with 0.05 mg reserpine and 2.5 mg clopamide, a patient subgroup of 34 patients followed a unicenter (central unit, 'institute') as well as a multicenter (established physicians) study design. The patients visited both investigation units on the day of admission to the study (week 0), after four weeks and after eight weeks of therapy (after the morning intake of the drugs). The paper in hand looks at the results of this subgroup with respect to the conformity of blood pressure values in the two investigative units. The analyses confirm the already published results of the entire study: Both combinations proved to be highly effective antihypertensive drugs. The triple combination showed therapeutical advantages for systolic blood pressure after four weeks, for diastolic pressure after eight weeks of therapy at the 'institute' as well as, although less distinct, in the medical offices. A comparison of the individual values did not show a convincing coherence of the measurements between institute and offices. All investigated possible systematic sources of error (different methods of measurement, days or times of measurement) could be excluded by correlation statistics as a reason for the divergences. The results show the necessity--particularly in multicenter studies--of a careful documentation of all accompanying data (e.g. method or time of measurement) as well as a greatest possible standardization of investigation (e.g. identical measuring apparatus and investigator.)

Antihypertensive Agents↗
PubMed1990

Quantification of the reversibility of stress-induced thallium-201 myocardial perfusion defects: a multicenter trial using bull's-eye polar maps and standard normal limits.

A multicenter trial was performed on 140 patients from four centers to determine the accuracy of quantitative analysis of stress/delayed thallium-201 myocardial tomograms using normal limits to assess the relative amount of reversibility of stress-induced defects. The patients were found to have 85 fixed and 124 reversible defects, as determined by visual interpretation. Reversibility bull's-eye polar maps were compared to gender-matched normal limits from 36 normals. Regions were identified as reversible if their normalized difference between stress and 4 hr greater than 1.5 s.d.s. from the mean normal limits. Overall agreement between experts at multicenter sites and reversibility maps was 73% for reversible defects and 80% of fixed defects. Sensitivity in detecting reversibility was highest for the left circumflex (88%) and lowest for the right coronary (60%). These results indicate that reversibility polar maps and normal limits offer an objective, accurate technique for determining the reversibility of stress-induced perfusion defects.

Adult↗
PubMed1993

[Preliminary results of the 2nd multicenter study. Thrombocytapheresis with the Fresenius AS-104 blood cell separator and ring study of cell counting. Section of Therapeutic and Preparative Hemapheresis of the DGTI].

Only multicenter studies on cell separators give valid data to compare different cell separators. The aim of the 2nd multicenter study was to evaluate the separation protocol, software version V 4.61, of the Fresenius AS-104 cell separator for efficiency and deviation from predicted yields. Plateletpheresis data from twelve hemapheresis centers, using identical apheresis protocols and cell counting methods, were registered and statistically analyzed. Additionally, the counting methods of the centers were controlled by a ring study with biweekly external cell count trials. To get a comparison, the apheresis data, which depend on the center effects, were corrected by the values from the ring study. Preliminary results of 380 runs are 45.2 +/- 8.1% for the separation effectivity, 1.95% deviation from the predicted yield, whereby 90% of all runs deviated less than 20% from the predicted yield. 50% of products had a WBC contamination below 6 x 10(6).

Blood Volume↗
PubMed1995

Quantitative myocardial SPECT for infarct sizing: feasibility of a multicenter trial evaluated using a cardiac phantom.

UNLABELLED: This study determined the feasibility of performing a multicenter trial using quantitative SPECT myocardial perfusion imaging in patients with acute myocardial infarction. The feasibility was assessed by a cardiac phantom. METHODS: Twenty-two gamma camera systems in 19 laboratories were evaluated. Each laboratory performed nine studies on the cardiac phantom and performed quality control tests of system uniformity, collimator quality and gantry alignment on their gamma camera system. Defects simulating "hypoperfused" myocardium of differing amounts were placed in the myocardium for eight of the nine studies. Measured defect size was compared to true defect size. RESULTS: A total of 198 studies from 22 systems were analyzed. Three studies were technically inadequate. For all 22 systems, the average correlation coefficient between true and measured defect size was 0.992 +/- 0.009, with a range from 1.00 to 0.97. Three systems were rejected due to slopes of the regression line outside the limits 1.00 +/- 0.10 and mean errors > 5% in estimating defect size. The remaining systems had a correlation coefficient of 0.995 + 0.008 with an average slope of 1.00 +/- 0.04 and an intercept of 0.11% +/- 1.57%. The mean error in estimating defect size was 2.08% +/- 0.69%. CONCLUSION: The small interlaboratory variation and the close correlation with true defect size observed in a cardiac phantom indicate the feasibility of quantitative myocardial SPECT as a useful tool in multicenter trials evaluating therapy in acute myocardial infarction. Preliminary objective testing is required, however, to identify systems with technical deficiencies.

Feasibility Studies↗
PubMed1995

The efficacy of Interceed(TC7)* for prevention of reformation of postoperative adhesions on ovaries, fallopian tubes, and fimbriae in microsurgical operations for fertility: a multicenter study. Nordic Adhesion Prevention Study Group.

OBJECTIVE: To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallopian tube, and fimbria when used together with microsurgical techniques. DESIGN: Prospective, randomized, multicenter, controlled clinical study. SETTING: Normal human volunteers in an academic research environment. PATIENTS: Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae. INTERVENTION: Adhesiolysis bilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the surgeon before application, follow-up laparoscopy 4 to 10 weeks postoperatively, with each patient serving as her own control. MAIN OUTCOME MEASURES: Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy. RESULTS: When the initial scores registered at the operation for fertility were compared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a significant reduction of postoperative adhesions. Adnexa, which were covered with Interceed, had significantly lower adhesion scores than the control adnexa, representing an improvement of 39% compared with microsurgery alone (control) in reducing adhesion reformation scores. When combined with microsurgical techniques, Interceed reduced adhesion reformation scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was significantly increased by approximately twofold when organs were covered with Interceed. CONCLUSION: In a prospective, randomized, multicenter, controlled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce significantly the incidence and severity of adhesion reformation to the ovary, fallopian tube, and fimbria after infertility surgery.

Cellulose, Oxidized↗
PubMed1994

[Report of initial experiences in establishing a regional multicenter evaluation of lymphocyte typing with flow cytometry].

Participation in a multicenter evaluation of flowcytometric investigations is the only possibility of providing external quality control. Up to now nine different laboratories have taken part in this program, measuring two samples of fresh EDTA blood according to a recommended antibody panel. The choice of antibodies was intended to reach a standardized immune status. Three different types of flowcytometers were used. All results were expressed in lymphocyte subset percentages and in absolute values. The coefficient of variation of each lymphocyte subpopulation was used for interpretation of the results of all working groups, as well as the control measurement. The results of the control measurement already showed that there was a difference between the obtainable coefficient of variation for the different subpopulations. In the case of CD3, CD4 and CD8 positive lymphocytes the relative percentages of the total group gave values far below 10%. The coefficients of variation of the activated T-lymphocytes or the cytotoxic T-cells, as well as of the absolute values were definitely higher. Already after the second multicenter evaluation the achieved results showed positive aspects such as improvements of the outcome, advancement of the user contacts, cooperation and impulses by discussing interesting problems.

Antigens, CD↗
PubMedDate not supplied

The Italian version of the Functional Disability Index of the Health Assessment Questionnaire. A reliable instrument for multicenter studies on rheumatoid arthritis.

A working group of ten rheumatology institutes (UNIREUM) was formed in Italy to promote multicenter therapeutic studies on rheumatoid arthritis. The Functional Disability Index (FDI) of the Health Assessment Questionnaire (HAQ) was chosen as a measure of disability. This paper reports the results of a multicenter study to validate an Italian translation of the instrument and to assess its reliability and validity. Two questions were modified to achieve cross-cultural equivalence. Back-translation into English showed agreement with the American instrument. Reproducibility was high: the test-retest correlation coefficient was 0.989 and ranged from 0.81 to 0.99 for the centers taken separately. Validity was confirmed by a correlation coefficient of 0.95 between the patient self-attributed and the physician-attributed FDI scores. We conclude that our Italian version of the HAQ FDI is a reliable and valid self-administered instrument.

Adult↗
PubMed1995

[Dilated cardiomyopathy: a new natural history? The experience of the Italian Multicenter Cardiomyopathy Study (SPIC)].

BACKGROUND: The natural history of idiopathic dilated cardiomyopathy (IDC), once a disease with a dire prognosis, is thought to be changing. Aim of this study was to describe the clinical characteristics, long term course and prognostic factors of IDC patients followed up prospectively since the late eighties. METHODS: Patients with a diagnosis of IDC confirmed by normal coronary angiography, non specific endomyocardial biopsy findings and a left ventricular ejection fraction below 50% were consecutively enrolled in a multicenter registry and followed up at 6-months intervals. RESULTS: From January 1986 till January 1994, 441 IDC patients with a mean age of 43 +/- 13 years (range 8-68) entered the registry. Thirty per cent of patients were women and 8% had familial dilated cardiomyopathy. NYHA class was I-II in 77% and 35% of patients were asymptomatic at the time of diagnosis. Treatment included digitalis in 235 patients (53%), diuretics in 239 (54%), angiotensin converting enzyme inhibitors in 269 (61%), betablockers in 108 (24%). Chronic atrial fibrillation was detected in 10% of patients and left bundle branch block in 24%. Mean cardiothoracic ratio was 0.54 +/- 0.06. Mean left ventricular end diastolic dimension was 38 +/- 6 mm/m2; 48% of patients had minimal or mild left ventricular dilatation. Mean left ventricular ejection fraction was 30 +/- 10%. At Holter monitoring 67% of cases had complex ventricular arrhythmias, 37% had ventricular tachycardia and 4% had advanced atrioventricular block. Mean exercise stress test duration was 9 +/- 4 minutes. After a mean follow up of 31 +/- 24 months, 337 patients were alive without transplantation and 5 were lost to follow up; 60 patients (14%) had died of cardiac causes, namely heart failure (6%), sudden death (7%) and pulmonary embolism (< 1%) and 30 had been transplanted (7%), while 4 had died of unclear causes. Survival and transplant-free survival were 94% and 90% at 2 years and 82 and 76% at 5 years, respectively. At multivariate analysis pulmonary capillary wedge pressure (p = 0.0001, odds ratio, for values > 15 mm Hg, 2.05) and betablocker treatment (p = 0.002, odds ratio 0.26) were independent predictors of survival. CONCLUSIONS: In this large, multicenter prospective study, prognosis of IDC in the eighties appears to be improved. Early diagnosis, together with improved medical treatment, probably bears a causal relation to these changes.

Adolescent↗
PubMedDate not supplied

[Use of Omniscan (gadodiamide) in magnetic resonance studies of the central nervous system (results of a multicenter study)].

The aim the study: was to conduct first in Russia multicenter trial of gadodiamide in brain and spine MRI in adult patients. Open noncomparative multicenter (5 clinical centres) study. Brain and spine MRI was performed in 190 adult patients with signs of CNS disorders. Field strength of MR imagers was 0.04-1.5 T. Gadodiamide ("Omniscan", "Nycomed Imaging", Nycomed) was injected IV in dose 0.1 mmol/ml. Contrast enhancement was obtained in 74% cases. Gadodiamide allowed to detect more new lesions, better differentiate borders and internal structure of lesions, to differentiate them from oedema and surrounding structures. Contrast-enhanced MR images were superior to non-enhanced T1 and T2-weighted images and to CT images (before and after contrast enhancement). Use of gadodiamide increased confidence in diagnoses in 90.4% cases, changed the diagnosis in 30.3% cases. The general number of adverse events was 2.6%. Adverse reactions to gadodiamide were seen in 1.6%; all of them were of mild intensity without need for therapy. Gadodiamide is an effective and safe nonionic paramagnetic contrast media for brain and spine MRI in adult patients.

Adolescent↗