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PubMed1985

Termination of clinical trials: the beta-blocker heart attack trial and the hypertension detection and follow-up program experience.

The close-out of clinical trials that end ahead of schedule often involves problems that differ from those of trials that end as planned. The Beta-Blocker Heart Attack Trial (BHAT), a double-blind study of 3837 post-myocardial infarction patients, was a multicenter clinical trial that ended early because therapeutic benefit had been demonstrated. The Hypertension Detection and Follow-up Program (HDFP), a randomized unblinded study of 10,940 hypertensive individuals, was a multicenter trial that ended as planned. Using these trials as illustrations, the issues arising in multicenter trials that end ahead of schedule are contrasted to those that arise in trials that end as scheduled. Close-out activities that are discussed include documentation of close-out procedures, release of trial information, preparation of trial participants and staff, ascertaining vital status, continuing patient care, data collection and coding, and publication of trial results. Because of the possibility a study might end early, advance planning for close-out is essential.

Adult↗
PubMedDate not supplied

Twenty years' experience of myocardial infarction: the value of a heart attack register.

Registers of disease serve a multitude of purposes, but are of particular importance to those interested in audit, in monitoring the introduction of new treatment or training programmes, in health service research, and in the planning of hospital services. The Nottingham Heart Attack Register has been in operation since 1973 and is proving to be an important data source. We present a brief history of the Register, describe how to set up a disease register and demonstrate how it can be of value to a wide range of health service staff using examples from our experience.

Emergency Medical Services↗
PubMed2001

Clinical Implications of Recent Findings from the Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT) and Other Studies of Hypertension.

Several recent comparative trials in hypertension have reported that similar blood pressure reductions may not necessarily translate into similar reductions in risk for cardiovascular complications. Thus, the method used to lower blood pressure may be important. In the Antihypertensive and Lipid-Lowering Treatment To Prevent Heart Attack Trial (ALLHAT), low-dose chlorthalidone as the first-line drug was superior to doxazosin. The 25% higher risk for major cardiovascular events associated with doxazosin was attributed primarily to a doubling in the risk for heart failure. A meta-analysis of patients with type 2 diabetes mellitus suggested that despite achieving similar blood pressure reductions, angiotensin-converting enzyme inhibitors are superior to other antihypertensive drugs in reducing the risk for acute myocardial infarction and cardiovascular events, but not stroke. Although individual comparative trials have failed to show conclusively that calcium-channel blockers differ from other antihypertensive drugs, a meta-analysis that included all published trials concluded that calcium-channel blockers are inferior to other classes of drugs in reducing the risk for acute myocardial infarction and heart failure. These observations suggest not only that antihypertensive drugs may have important mechanisms of action apart from blood pressure lowering but also that effective treatment is not a matter of simply lowering blood pressure. These findings have potential implications for the regulatory approval of antihypertensive agents, revisions of treatment guidelines, the design of future randomized trials comparing different antihypertensive drugs and, most important, the selection of drugs for the treatment of hypertensive patients.

Antihypertensive Agents↗
PubMed1983

Intervention with heart attack patients and families.

Workers who attend to a stage model of acute illness can create linkage with other problems and events to effectuate a comprehensive and dynamic plan of intervention. A systematized approach is proposed to effectively understand the psychological reactions to illness manifested by heart attack patients and their families.

Hospitals↗
PubMed1975

Coronary heart-attacks in East London.

All cases of cardiac infarction, acute coronary insufficiency and sudden death occurring in residents of the London Borough of Tower Hamlets below age 65 were registered over nearly three years, and survivors were followed up for one year. The attack-rate in men aged 45-64 years was 1 per 100 per annum but the recurrence-rate in survivors was 1 per 100 per month. Immigrants from Asia had more than the average, and those from the Carribean one tenth of the average attack-rate. Although it was unusual for general practitioners to manage cases at home by choice, nonetheless two-thirds of the deaths happened outside hospital and half of these were not witnessed. Half of those suffering coronary heart-attacks had a previous history of coronary disease and a sizable minority were already unfit for work. Approximately half of those attacked were alive at one year.

Acute Disease↗
PubMed1995

Success of cardiopulmonary resuscitation after heart attack in hospital and outside hospital.

OBJECTIVES: To determine factors associated with cardiopulmonary resuscitation being attempted after cardiac arrest from myocardial infarction, in or outside hospital, and estimate short term and long term survival rates. DESIGN: Descriptive cross sectional and cohort study. SETTING: Community based register of all suspected heart attacks and sudden cardiac deaths in Lower Hunter region of New South Wales, Australia. SUBJECTS: 4924 men and women aged 25-69. MAIN OUTCOME MEASURES: Rates of attempted cardiopulmonary resuscitation and survival after successful resuscitation. RESULTS: Cardiopulmonary resuscitation was attempted in 41% of cases of cardiac arrest after myocardial infarction outside hospital and 63% of cases in hospital. Survival rates at 28 days were 12% and 39% respectively. Among the survivors, although 41% had another myocardial infarction (or coronary death), 81% of both groups were still alive two years later. Younger and better educated people were more likely to receive cardiopulmonary resuscitation in either setting, and being married predicted cardiopulmonary resuscitation being attempted outside hospital. Younger age predicted better survival rates after attempted resuscitation in hospital. CONCLUSIONS: The reasons for better education to predict cardiopulmonary resuscitation being attempted need explanation. The higher survival rate after cardiopulmonary resuscitation in hospital compared with outside hospital and the good long term prognosis for survivors in both settings suggest that attempts to improve success of cardiopulmonary resuscitation outside hospital may be worth while.

Adult↗
PubMed1988

Prediction of men at high risk of heart attack and its relevance to pilots.

In this paper we have extrapolated from data on the general population of middle-aged men and made suggestions for risk prediction and prevention policy in aircrew. As suggested previously, it would be helpful in future if data on the risk of heart attack in pilots could be generated from a central recording system covering both current pilots and those who retire for whatever reason. Indefinite follow-up information on ischaemic events would also be particularly helpful.

Adult↗
PubMed1983

Stressful life events: a predictor in recovery from heart attacks.

Early identification of cardiac patients at risk for problems in recovery can be of help to social workers who work in crowded inpatient services. The study described here found preonset stress, measured by a stressful life events questionnaire, to be associated with the level of recovery from a heart attack. The questionnaire may be a valuable tool for social workers working with cardiac patients.

Adult↗
PubMed1981

Risk factors for fatal heart attack in young women.

Deaths of 338 women at ages 15-44 years attributed to myocardial infarction (MI) on death certificates during an 18-month period in five metropolitan areas were investigated. Evidence of recent MI or evidence that death occurred suddenly was obtained for about half (163) from records of hospitals or medical examiners or from relatives. A case-control study (involving one deceased control, and one hospitalized living control) of risk factors for heart attack was then conducted using interviews with relatives and abstracts of records of hospitals and physicians identified by the relatives as sources of medical care. Information was obtained on history of prior MI, other heart disease, diabetes, thromboembolism, stroke, hypertension, high cholesterol, obesity, oophorectomy, oral contraception and cigarette smoking. Data are presented on the prevalence of these potential risk factors for the case group and each control group, and for subsets of cases consisting of those without prior heart disease, definite MI only, sudden death only, and white women only. Multivariate analyses identify somewhat different sets of risk factors and different levels of risk for the various subgroups. In general, the risk factors are those that have been reported for men, despite the major difference in level of mortality.

Adolescent↗
PubMed1990

Propranolol-induced lipid changes and their prognostic significance after a myocardial infarction: the Beta-Blocker Heart Attack Trial experience.

Beta blockers represent the only documented effective long-term prophylactic treatment for patients after myocardial infarction (MI). Concern continues to be expressed about the lipid-altering effects of their long-term use, especially beta blockers without intrinsic sympathomimetic activity such as propranolol. Data collected for the Beta-Blocker Heart Attack Trial, the largest long-term clinical trial of beta-blocker use in patients after MI, have been analyzed to address the following questions. To what extent does propranolol alter lipid levels at least 6 months after MI and initiation of therapy? How predictive of subsequent coronary events and mortality are lipid levels 6 months after MI? Is there any evidence that altered lipid levels attenuate any of the beneficial effect of propranolol on coronary morbidity and mortality? By the 6-month post-MI visit, propranolol was shown to raise serum triglyceride levels by about 17% (approximately equal to 35 mg/dl) and lower serum high density lipoprotein (HDL) cholesterol by about 6% (approximately equal to 3 mg/dl). There was no effect on total cholesterol or low density lipoprotein cholesterol. In other analyses, no lipid measured 6 months after the MI was strongly predictive of subsequent coronary events or mortality. For example, every 1-mg-lower HDL value was associated with only a 0.7% relative increase in the mortality rate. Theoretically, the estimated relative increase on all-cause mortality associated with propranolol-induced HDL reduction is about 2%. In multivariate analyses adjusting for changes in HDL and serum triglyceride, propranolol-induced beneficial reductions in mortality and morbidity remained on the order of 20%, 10 times the estimated hazard.

Adult↗
PubMed1982

The effect of psychological intervention on recovery from surgery and heart attacks: an analysis of the literature.

A quantitative review of 34 controlled studies demonstrates that, on the average, surgical or coronary patients who are provided information or emotional support to help them master the medical crisis do better than patients who receive only ordinary care. A review of 13 studies that used hospital days post-surgery or post-heart attack as outcome indicators showed that on the average psychological intervention reduced hospitalization approximately two days below the control group's average of 9.92 days. Most of the interventions were modest and, in most studies, were not matched in any way to the needs of particular patients or their coping styles. Beyond the intrinsic value of offering humane and considerate care, the evidence is that psychological care can be cost-effective.

Adult↗
PubMed1990

Effects of propranolol in non-Q-wave acute myocardial infarction in the beta blocker heart attack trial.

Although the beneficial effects of long-term therapy with beta-adrenergic blocking agents in patients recovering from acute myocardial infarction (AMI) are established, the effect of this therapy on the cardiac event rate in patients recovering from a non-Q-wave AMI is unknown. This post hoc analysis of the Beta Blocker Heart Attack Trial (BHAT) evaluates the effects of daily administration of propranolol 180 or 240 mg/day after non-Q-wave AMI. The study population consisted of 601 patients with enzymatically proven non-Q-wave AMI, which represented 17% of the BHAT patients. Of these, 310 patients were randomized to receive propranolol and 291 patients to placebo. There were no significant baseline differences between groups. The median follow-up was 24.6 months. Mortality was 7.8% (sudden death 4.8%) in the propranolol group and 7.9% (sudden death 4.8%) in the placebo group (p greater than 0.99, log rank test). Reinfarction rate was 7.4% in the propranolol group and 6.5% in the placebo group (p greater than 0.63, log rank test). The need for coronary bypass surgery was similar in the 2 groups. However, more patients randomized to placebo developed angina. In this post hoc group analysis of the BHAT, propranolol was not shown to be beneficial in reducing the cardiac event rate in patients recovering from a non-Q-wave AMI.

Double-Blind Method↗
PubMed1999

Differences in management of heart attack patients between metropolitan and regional hospitals in the Hunter Region of Australia.

OBJECTIVES: To test the hypothesis that among patients with acute myocardial infarction (AMI) length of hospital stay, drug use in hospital and on discharge were different between metropolitan and regional hospitals after adjusting for differences in patient baseline risk. METHODS: A retrospective cohort study using a community-based register of heart attack patients assessed 1,406 patients admitted for definite AMI to three metropolitan and five regional hospitals in the Lower Hunter Region of NSW, between January 1, 1990, and March 31, 1994. RESULTS: Patients in metropolitan hospitals were significantly less likely to stay in hospital for more than seven days (adjusted odds ratio = 0.50; 95% CI 0.34-0.73), significantly more likely to receive ACE inhibitors (adj. OR = 1.47; 1.27-1.71) and less likely to receive calcium channel blocker (adj. OR = 0.70; 0.54-0.98). Regardless of disease severity, metropolitan hospitals had a higher percentage of patients for whom drugs shown to decrease mortality after AMI were used (streptokinase, aspirin, ACE inhibitor); a lower percentage of patients received drugs shown to have no benefit or even a detrimental effect (calcium channel blocker). Both groups had relatively low use of beta blocker, also shown to be of benefit. CONCLUSIONS: Regional hospitals had longer hospital stays than metropolitan hospitals and less use of drugs of proven benefit.

Adult↗
PubMedDate not supplied

Success and predictors of blood pressure control in diverse North American settings: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT).

CONTEXT: Blood pressure control (<140/90 mm Hg) rates for hypertension fall far short of the US national goal of 50% or more. Achievable control rates in varied practice settings and geographic regions and factors that predict improved blood pressure control are not well identified. OBJECTIVE: To determine the success and predictors of blood pressure control in a large hypertension trial involving a multiethnic population in diverse practice settings. DESIGN: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial is a randomized, double-blind, active-controlled clinical trial with a mean follow-up of 4.9 years. Participant enrollment began in February 1994 and follow-up was completed in March 2002. SETTING: A total of 623 centers in the United States, Canada, and the Caribbean. PARTICIPANTS: A total of 33,357 participants (aged > or =55 years) with hypertension and at least one other coronary heart disease risk factor. INTERVENTIONS: Participants were randomly assigned to receive (double-blind) chlorthalidone, 12.5-25 mg/d (n=15,255), amlodipine 2.5-10 mg/d (n=9048), or lisinopril 10-40 mg/d (n=9054) after other medication was discontinued. Doses were increased within these ranges and additional drugs from other classes were added as needed to achieve blood pressure control (<140/90 mm Hg). MAIN OUTCOME MEASURES: The outcome measures for this report are systolic and diastolic blood pressure, the proportion of participants achieving blood pressure control (<140/90 mm Hg), and the number of drugs required to achieve control in all three groups combined. RESULTS: Mean age was 67 years, 47% were women, 35% black, 36% diabetic; 90% were on antihypertensive drug treatment at entry. At the first of two pre-randomization visits, blood pressure was <140/90 mm Hg in only 27.4% of participants. After 5 years of follow-up, the percent controlled improved to 66%. Systolic blood pressure was <140 mm Hg in 67% of participants, diastolic blood pressure was <90 mm Hg in 92%, the mean number of drugs prescribed was 2.0+/-1.0, and the percent on > or =2 drugs was 63%. Blood pressure control varied by geographic regions, practice settings, and demographic and clinical characteristics of participants. CONCLUSIONS: These data demonstrate that blood pressure may be controlled in two thirds of a multiethnic hypertensive population in diverse practice settings. Systolic blood pressure is more difficult to control than diastolic blood pressure, and at least two antihypertensive medications are required for most patients to achieve blood pressure control. It is likely that the majority of people with hypertension could achieve a blood pressure <140/90 mm Hg with the antihypertensive medications available today.

Aged↗