Search PubMed⌕ Search

Biomedical subjects

E Santoro

Publications and source records attributed to E Santoro.

At least 37 records · Page 2Linked to original sources
PubMed2000

Clinical effects of early angiotensin-converting enzyme inhibitor treatment for acute myocardial infarction are similar in the presence and absence of aspirin: systematic overview of individual data from 96,712 randomized patients. Angiotensin-converting Enzyme Inhibitor Myocardial Infarction Collaborative Group.

OBJECTIVES: We sought to determine whether the clinical effects of early angiotensin-converting enzyme (ACE) inhibitor (ACEi) treatment for acute myocardial infarction (MI) are influenced by the concomitant use of aspirin (ASA). BACKGROUND: Aspirin and ACEi both reduce mortality when given early after MI. Aspirin inhibits the synthesis of vasodilating prostaglandins, and, in principle, this inhibition might antagonize some of the effects of ACEi. But it is uncertain whether, in practice, this influences the effects of ACEi on mortality and major morbidity after MI. METHODS: This overview sought individual patient data from all trials involving more than 1,000 patients randomly allocated to receive ACEi or control starting in the acute phase of MI (0-36 h from onset) and continuing for four to six weeks. Data on concomitant ASA use were available for 96,712 of 98,496 patients in four eligible trials (and for none of 1,556 patients in the one other eligible trial). RESULTS: Overall 30-day mortality was 7.1% among patients allocated to ACEi and 7.6% among those allocated to control, corresponding to a 7% (standard deviation [SD], 2%) proportional reduction (95% confidence interval 2% to 11%, p = 0.004). Angiotensin-converting enzyme inhibitor was associated with similar proportional reductions in 30-day mortality among the 86,484 patients who were taking ASA (6% [SD, 3%] reduction) and among the 10,228 patients who were not (10% [SD, 5%] reduction: chi-squared test of heterogeneity between these reductions = 0.4; p = 0.5). Angiotensin-converting enzyme inhibitor produced definite increases in the incidence of persistent hypotension (17.9% ACEi vs. 9.4% control) and of renal dysfunction (1.3% ACEi vs. 0.6% control), but there was no good evidence that these effects were different in the presence or absence of ASA (chi-squared for heterogeneity = 0.4 and 0.0, respectively; both not significant). Nor was there good evidence that the effects of ACEi on other clinical outcomes were changed by concomitant ASA use. CONCLUSIONS: Both ASA and ACEi are beneficial in acute MI. The present results support the early use of ACEi in acute MI, irrespective of whether or not ASA is being given.

Aged↗
PubMed2000

Spectral and bidirectional filters give different results for signal-averaged ECG analysis in patients with postmyocardial infarction. GISSI-3 Arrhythmias Substudy Investigators.

This study aims at assessing the specific effects of bidirectional filters (BF) and spectral filters (SF) on signal-averaged ECG (SAECG) analysis. The GISSI-3 Arrhythmias Substudy collected SAECGs of 598 patients 10 +/- 4 days after myocardial infarction (MI) from 20 Italian coronary care units. BF and SF were applied on 340 and 258 patients, respectively. QRS duration (QRSD), low amplitude signal duration (LAS40), and root mean-square-voltage (RMS40) were measured with filters set at 40 to 250 Hz. For ventricular late potentials (VLP) detection filter-specific criteria were adopted: QRSD > 114 ms, LAS40 > 38 ms, RMS40 < 20 microV for BF and QRSD > 120 ms, LAS40 > 38 ms, RMS40 < 20 microV for SF. VLP were considered present if any 2 of the criteria were met. The QRSD obtained by BF (100.6 +/- 13 ms) was shorter (P < .0001) than that obtained by SF (109.1 +/- 12 ms). Nevertheless, a higher prevalence of VLP for patients with BF than for patients with SF was found (23.8% vs 16.7%; P < .04). Indeed, filter-specific criteria were able to avoid any differences in the prevalence of abnormal QRSD and LAS40, but not of RMS40 (25.6% vs 17.1%, P < .02). Finally, the difference of VLP prevalence was mainly owing to the higher number of abnormal pairs of RMS40 + LAS40 (58% vs 44%) for BF than for SF. This multicentric study suggests that after MI, BF and SF produce discordant results on low-amplitude signals of filtered QRS that are not avoided by adopting filter-specific criteria. On the contrary, specific criteria seem to be suitable for comparison of QRSD between different SAECG devices in post-MI patients.

Action Potentials↗
PubMed1999

The influence of smoking on von Willebrand factor is already manifest in healthy adolescent females: the Floren-teen (Florence Teenager) Study.

The early onset of atherosclerosis and the involvement of physiological biochemical, and environmental factors in its pathogenesis is well documented. Few data are available on the role of risk factors related to hemostasis in the pathogenesis of atherosclerosis in the young and, in particular, little information is available on adolescent populations. In the Study of Preventive Medicine and Education Program (Floren-teen Study), von Willebrand factor, a risk factor for cardiovascular disorder, was studied, together with classical cardiovascular risk factors, in apparently healthy students from two high schools in Florence. Familial and personal history, physical examination, and cardiovascular risk factors were evaluated in 144 students (aged 17-19 years). Blood was withdrawn to assess von Willebrand factor (ELISA) and lipid parameters. Levels of von Willebrand factor were significantly higher (P<0.044) in smokers than in nonsmokers and were correlated with the number of cigarettes per day in the whole group (P=0.01) and in females (P=0.006). In females a positive correlation was observed between von Willebrand factor and high-density lipoprotein cholesterol (P=0.0365). There was no significant correlation between von Willebrand factor and blood pressure or between von Willebrand factor and physical activity. In conclusion, this study shows an association between levels of von Willebrand factor and smoking habits and is the first show that even a brief period of smoking affects levels of von Willebrand factor in healthy adolescent females independently of other risk factors. These results stress the relevance of extending prevention programs to reduce smoking in high school students.

Adolescent↗
PubMed1999

[Klatskin tumor. A study of 15 resected cases].

STUDY AIM: Klatskin tumors are rare. Prognosis is still poor, and long term survival can be expected only after surgery, which is the treatment of choice. The aim of this study is to report the results of 15 resected cases and, by analysis of the literature, to emphasize the progress of the surgical treatment in hilar cholangiocarcinoma. PATIENTS AND METHODS: Between 1990 and 1998, 27 patients affected by Klatskin tumor were observed. Eight women and seven men underwent surgical resection. The mean age was 59 years. Thirteen patients (48%) had curative resection (7 hilar resection (HR), 5 HR combined with partial hepatectomy (PH) and 1 HR + PH with portal vein resection). Two patients had palliative resection and surgical drainage. RESULTS: One in-hospital death occurred right after hepatectomy with portal vein resection (6.6%). Postoperative morbidity was 40%. Patients were regularly followed. Ten patients died and 5 were alive at the time of this study. The 1, 2 and 3-year survival after a curative resection was 84%, 54% and 34%. The median survival was 28.5 months. Lymph node involvement did not show a statistically significant difference on median survival between the positive group and the negative group (26.2 vs 29.8 months) because of the small number of patients. Survival after hilar resection at 1, 2, 3, and 5 years was 100%, 57.1%, 28.6% and 0%. Four out of the 6 patients who underwent hilar resection combined with partial hepatectomy were still alive 1, 23, 29, 38 months after resection. Hepatectomy increased mortality (16% vs 0%). Palliative biliary resection and surgical drainage were successfully performed in 2 patients. CONCLUSION: Aggressive surgical treatment of Klatskin tumor can improve the survival of patients. Careful pre-operative management has to be carried out by a multidisciplinary approach including surgeons, hepatologists, radiologists and pathologists. Hepatic resection including the caudate lobe is often performed in order to obtain microscopic tumor-free margins and curative resection (R0). Biliary drainage and treatment of cholangitis is mandatory before surgery in order to improve the surgical outcome. Surgical treatment is characterized by high technical difficulties, and better results can be achieved by hepatobiliary surgical teams.

Adult↗
PubMed1999

Very early assessment of risk for in-hospital death among 11,483 patients with acute myocardial infarction. GISSI investigators.

BACKGROUND: The efficacy of reperfusion therapy after acute myocardial infarction is time dependent. The risk profile of every patient should be available as soon as possible. Our aim was to determine whether collection of simple clinical markers at hospital admission might allow reliable risk stratification for in-hospital mortality. METHODS: The subjects were 11,483 patients with acute myocardial infarction from the GISSI-2 cohort. The GISSI-1 and GISSI-3 populations were selected to validate the classification. To stratify patients, the tree-growing method called recursive partitioning and amalgamation (RECPAM) was used. This method is used to identify homogeneous and distinct subgroups with respect to outcome. RESULTS: The RECPAM algorithm provided 6 classes. RECPAM class I included Killip class 3 to class 4 patients (516 deaths/1000). RECPAM class II included Killip 2 patients older than 66 years and with anterior infarction or sites of infarction that could not be evaluated (314 deaths/1000). Killip 1 patients older than 75 years and with anterior or multiple sites or sites that could not be evaluated were included in RECPAM class III with Killip class 2 patients younger than 66 years and with systolic blood pressure less than 120 mm Hg or older than 66 years and with any other infarction site (207 deaths/1000). The other classes showed lower mortality rates (91, 32, and 12 deaths/1000 for RECPAM classes IV, V, and VI). In the GISSI 1 and GISSI 3 samples the 6 classes ranked in the same order in terms of mortality rate. With respect to low-risk strata, patients belonging to RECPAM class VI without serious clinical events in the first 4 days had a very low incidence of in-hospital death (0.9%) or morbidity. Cumulative 6-month mortality for the 6 RECPAM classes was 59.6%, 41.2%, 26.4%, 12.9%, 4. 8%, and 2.2%. CONCLUSIONS: Four simple clinical markers readily available at admission of patients with myocardial infarction allow a quick, reliable, and inexpensive prediction of risk for in-hospital and 6-month mortality. The RECPAM classification also helped identify a large subgroup of patients fit for early hospital discharge.

Aged↗
PubMed1999

Telecommunication technology for the management of large scale clinical trials: the Gissi experience.

The Coordinating Centre (CC) of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico (GISSI) used telecommunication technology to develop a computerized network system for the data management of the GISSI studies. Through a personal computer (PC), a communication program, a modem and a telephone line, the investigator in each participating centre can connect with a micro-computer at the CC, to recruit/randomize patients and download reports on the progress of the trial. In the first case, the investigator is required to answer a set of predefined questions, and thereby the system automatically checks eligibility criteria and randomly assigns the patient to a treatment arm. In the second case, once the investigator has made a choice from a list of standard reports and the relative query on CC central database, the generation, the formatting and the transfer of the selected report to the PC are executed automatically on line. The main advantages of this system are a reduction in number of mistakes in data completion and in the human and economic resources required, as well as the real time updating of participating centres. The system was successfully adopted in the GISSI-3 trial (200 Coronary Care Units and 19,394 patients enrolled), in the European arm of the CORE trial and it is currently being used in the GISSI-Prevenzione trial.

Algorithms↗
PubMed1999

Internet for clinical trials: past, present, and future.

The Internet and World Wide Web have recently been introduced into the management of some aspects of large-scale clinical trials such as remote randomization and data entry and the distribution of information on trial progress. Electronic mail and websites have also been used to enhance communication among people involved in a clinical trial. The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico acuto (GISSI) used telecommunications and the Internet in some recent large-scale clinical trials. GISSI constructed a website to keep the medical and cardiology community informed about the progress of its studies. Websites for clinical trials could play an important role in the future, especially in international clinical trials. The website could provide information such as study material and study news and tools such as electronic forums on protocol application for use by investigators around the world. This article describes the GISSI experience and outlines an appropriate structure for a clinical trial website.

Clinical Trials as Topic↗
PubMed1999

Serum homocysteine, MTHFR gene polymorphism, and carotid intimal-medial thickness in NIDDM subjects.

We assessed the contribution of serum homocysteine levels, an independent risk factor for vascular disease, and of the methylenetetrahydrofolate reductase (MTHFR) C677T mutation to the variability of carotid intimal-medial thickness (IMT) in patients with non-insulin-dependent diabetes mellitus (NIDDM). Ninety-five patients (33 males and 62 females, mean age 53 +/- 10 years) without nephropathy or other vascular complications were enrolled. Fasting total serum homocysteine and other biochemical analytes were measured. The MTHFR polymorphism was determined by the polymerase chain reaction. Common carotid IMT and plaques or stenoses in the carotid district were measured by ultrasonography. Serum total homocysteine concentrations were higher in subjects with the mutant (Val/Val) genotype than in those with the Ala/Val plus Ala/Ala genotypes (P = 0.02). On univariate analysis, carotid IMT was significantly associated with age, body mass index (BMI), systolic blood pressure, and total cholesterolemia. No significant association was found between IMT and serum homocysteine or the MTHFR polymorphism, although a slightly greater IMT was observed in the homozygous Val genotypes. On multiple regression analysis, only age and BMI were independently associated with IMT and explained about 40% of IMT variability. The results did not change when the analysis was restricted to the subgroups with or without atherosclerotic plaques in the carotid district. In 95 Italian NIDDM patients without nephropathy, neither basal levels of serum total homocysteine nor the MTHFR C677T polymorphism predicted significant changes in common carotid intimal-medial thickness.

Arteriosclerosis↗
PubMed1999

Pancreatic resections: early results and functional behaviour of the stapled pancreatic stump.

Pancreaticoduodenectomy is the standard surgical treatment for patients with pancreatic head cancer. Morbidity and mortality rates following this procedure have constantly decreased over the past several years. Leakage of the pancreaticoenteric anastomosis is one of the most serious complications, often responsible for a fatal outcome. Several methods for the management of the pancreatic stump have been described in order to reduce the worrisome incidence of this complication, with variable results. In this series, the Authors review their experience of 75 pancreatic resections and analyze the early results and functional behaviour of 6 patients in which the pancreatic stump was stapled without pancreaticoenteric anastomosis.

Adenocarcinoma↗
PubMed1998

Ten-year follow-up of the first megatrial testing thrombolytic therapy in patients with acute myocardial infarction: results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study. The GISSI Investigators.

BACKGROUND: We conducted a 10-year follow-up of the 11 712 patients with acute myocardial infarction randomized in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-1 study, the first large trial assessing thrombolytic therapy. METHODS AND RESULTS: Information on survival at 10 years was obtained for the 93% of all randomized patients through the census offices of their towns of residence. The difference in survival produced by streptokinase and sustained up to 1 year was still significant at 10 years (log-rank test, P=0.02), with the absolute benefit of 19 (95% CI 1 to 37) lives saved per 1000 patients treated. The time dependence of the extent of the benefit was confirmed, as the higher mortality rate reductions found in patients treated earlier were still present at 10 years. In the overall population, most of the benefit was obtained before hospital discharge (RR 0.81, 95% CI 0.72 to 0.90), since no difference in survival between thrombolyzed and control patients discharged alive was found at 10 years (RR 0.98, 95% CI 0.90 to 1.06). However, a slight albeit nonsignificant divergence of the survival curves of patients randomized within the first hour was observed [90 (95% CI 34 to 146) lives saved per 1000 at 10 years versus 72 (95% CI 37 to 107) lives saved at hospital discharge]. CONCLUSIONS: The benefits of a single intravenous infusion of 1.5 million units of streptokinase in prolonging survival of patients with acute myocardial infarction is sustained up to 10 years, with a still-evident trend in favor of the patients admitted earlier.

Age Factors↗
PubMed1998

Loss of FHIT expression in gastric carcinoma.

Loss of heterozygosity involving the short arm of chromosome 3 has been reported in gastric and other human tumors. We have cloned and mapped a candidate tumor suppressor gene, FHIT (fragile histidine triad), to this chromosomal region (3p14.2). To investigate the role of FHIT gene alterations in the development of gastric carcinoma, we examined 8 gastric carcinoma-derived cell lines and 32 primary adenocarcinoma samples by Southern blot analysis. We also analyzed the integrity of FHIT transcripts by reverse transcription-PCR. The occurrence of alterations in the FHIT gene and its transcript correlated with the absence of Fhit protein expression by immunoblot analysis in the cancer cell lines. Four of eight cell lines showed deletion or rearrangement within the FHIT gene, together with the absence of the wild-type transcript and the Fhit protein. Among the primary gastric carcinomas, rearrangement of the FHIT gene and/or aberrant reverse transcription-PCR products were detected in 17 of 32 (53%) tumors, and 20 of 30 (67%) samples exhibited an absence of Fhit protein expression. Gastric cancer is thought to develop from carcinogenic exposure, possibly explaining the high frequency of abnormalities in the FHIT gene, a fragile locus exhibiting susceptibility to carcinogen-induced alterations. The consequent absence or reduction of Fhit protein expression is consistent with the proposal that the FHIT gene is a preferential target of environmental carcinogens and that FHIT inactivation plays a role in the development of gastric cancer.

Acid Anhydride Hydrolases↗
PubMed1998

Predischarge two-dimensional echocardiographic evaluation of left ventricular thrombosis after acute myocardial infarction in the GISSI-3 study.

Left ventricular (LV) thrombosis can be found in patients with acute myocardial infarction (AMI). No wide multicenter trial on AMI has provided information about LV thrombosis until now. The protocol of the GISSI-3 study included the search for the presence of LV thrombosis in patients from 200 coronary care units that did not specifically focus on LV thrombosis. We examined the GISSI-3 database results related to 8,326 patients at low to medium risk for LV thrombi in which a predischarge echocardiogram (9 +/- 5 days) was available. LV thrombosis was found in 427 patients (5.1%): 292 of 2,544 patients (11.5%) with anterior AMI and in 135 of 5,782 patients (2.3%) with AMI in other sites (p <0.0001). The incidence of LV thrombosis was higher in patients with ejection fraction < or = 40% (151 of 1,432 [10.5%] vs 276 of 6,894 [4%]; p <0.0001) both in the total population and in the subgroup with anterior AMI (106 of 597 [17.8%] vs 186 of 1,947 [9.6%]; p <0.0001). Multivariate analysis showed that only the Killip class > I and early intravenous beta-blocker administration were independently associated with higher LV thrombosis risk in the subgroup of patients with anterior AMI (odds ratio 1.75, 95% confidence interval 1.28 to 2.39; odds ratio 1.32, 95% confidence interval 1.02 to 1.72, respectively). In patients with anterior AMI, oral beta-blocker therapy given or not given after early intravenous beta-blocker administration does not influence the occurrence of LV thrombosis. The rate of LV thrombosis was similar in patients treated or not treated with nitrates and lisinopril both in the total population and in patients with anterior and nonanterior AMI. In conclusion, in the GISSI-3 population at low to medium risk for LV thrombi, the highest rate of occurrence of LV thrombosis was found among patients with anterior AMI and an ejection fraction < 40%. Killip class > I and the early intravenous beta-blocker administration were the only variables independently associated with a higher predischarge incidence of LV thrombosis after anterior AMI.

Adrenergic beta-Antagonists↗
PubMed1998

Neurophysiological evaluation of sexual dysfunction in patients operated for colorectal cancer.

Sexual dysfunction after colorectal cancer surgery may be severe and occurs in 25% to 100% of cases. Thirty-eight patients underwent colorectal resection; eight (21%) who were totally impotent and two (5%) who had ejaculatory failure were therefore studied to better understand the neurophysiological alterations related to this type of surgery. The patients were evaluated after surgery with electrophysiological testing, including examination of the sacral reflex (SR), pudendal somatosensory evoked potential (PEP), and motor evoked potential (MEP) responses. Sudomotor skin response (SSR) was also studied in a group of patients. Of the 38 patients studied, 29 showed abnormalities: six of SR, three of PEP, six of MEP, and fourteen of SSR. Only a combination of all these tests permits correct evaluation of the sexual dysfunction.

Adenocarcinoma↗
PubMed1998

Epidemiology of post-infarction risk stratification strategies in a country with a low volume of revascularization procedures. GISSI-Prognosis Investigators.

AIMS: The aims of the GISSI Prognosis Registry were to describe the diagnostic strategies initiated in acute myocardial infarction patients by a representative sample of Italian cardiological centres, and to determine which clinical or hospital characteristics were associated with the initiation of invasive diagnostic or therapeutic procedures. METHODS AND RESULTS: Baseline characteristics, major in-hospital events and the indication and results of invasive and non-invasive procedures were collected on 1489 acute myocardial infarction patients discharged alive from 65 Italian cardiological centres over a period of 3 months. Twenty-five percent of centres had on site catheterization laboratories while the rest did not. Statistical significance was analysed by chi-square tests for categorical variables. A two-sample Student t-test was used to compare continuous variables. The adjusted analysis was performed utilizing multiple logistic regression models. The most performed procedures were standard, non-invasive: 57.8% of the patients underwent an exercise stress test, 70.8% ambulatory ECG monitoring and 95.6% two-dimensional echocardiography. Nuclear or echocardiographic imaging tests were performed in 40% of acute myocardial infarction survivors. Overall, coronary angiography was planned in 549 patients (36.9%). Variables independently associated with the indication for coronary angiography were residual ischaemia, younger age, contraindication to exercise stress testing, level of patients' education, higher volume of non-invasive diagnostic tests, and male sex. Overall, during a 6-month follow-up period, coronary angiography, percutaneous transluminal coronary angioplasty and coronary artery bypass surgery were performed, respectively in 35%, 10% and 8% of the study population. CONCLUSIONS: The setting where cardiologists practise determines the patterns of care in acute myocardial infarction patients more than the characteristics of the patient. The absence of evidence-based guidelines on the more complex and expensive procedures favour empirical attitudes and practices. The confirmation in a prospective cohort of patients, which aims to represent the care of a whole country, suggests that more effort should be given to the implementation of controlled studies rather than periodical reformulation of guidelines not supported by hard data.

Aged↗
PubMed1998

Cost-effectiveness analysis of early lisinopril use in patients with acute myocardial infarction. Results from GISSI-3 trial.

The cost effectiveness of early treatment with lisinopril in acute myocardial infarction (MI) was estimated using survival and cost data gathered prospectively during the hospitalisation of the overall population of patients enrolled in the third study of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto (GISSI-3), which assessed the efficacy of early (within 24 hours) treatment with an angiotensin-converting enzyme (ACE) inhibitor (lisinopril) for 6 weeks in a group of 19,394 relatively unselected patients with acute MI. A statistically significant reduction in 6-week mortality was achieved among patients treated with lisinopril when compared with patients allocated to the control group (absolute reduction in mortality: 7.5 +/- 3.6 lives saved per 1000 treated patients). The comparative cost-effectiveness ratio for the use of lisinopril, expressed as cost per additional survivor among patients randomised to receive lisinopril, was $US2080 per life saved (1993 values). The sensitivity analysis conducted to examine the effects of varying the estimated absolute reduction in mortality throughout its 95% confidence interval, which ranged from 14.6 to 0.4 lives saved per 1000 treated patients, showed that the cost-effectiveness ratios consequently vary from $US1121 to $US40,910 per life saved. The cost effectiveness of early treatment with lisinopril of a relatively unselected population of patients with acute MI compares very favourably with that of other therapies judged to be worthwhile by the medical community.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1998

[Surgical resection of lung metastases from breast cancer. Report of 12 cases].

Thirty-nine patients affected with lung metastases from different primary neoplastic sites have been treated between 1990 and 1998 at 2nd Surgical Division of "Regina Elena" National Cancer Institute of Rome. Among them, 12 were metastases from breast cancer-lung metastases were isolated in 9 cases and multifocal in 3 cases, although always in the same lung. Nine cases underwent a thoracotomic approach: in 6 patients we have performed a wedge resection, in 3 cases a lobectomy. Three patients underwent a wedge resection by means of a video-thoracoscopic approach. We have registered 2 post-operative complications and no deaths. Median survival rate was 40 months and 5 year actuarial survival rate was 42%. Surgery for isolated lung metastases seen to be a safe approach and to improve life expectancy in most of patients.

Adult↗