High homocysteine levels are independently related to isolated systolic hypertension in older adults.

Background: The association between homocysteine and isolated systolic hypertension in older adults was evaluated using a case-control design, and the relationship between homocysteine and clinical or subclinical atherosclerosis was explored.

Methods And Results: Cases were 179 adults > or = 60 years with a systolic blood pressure of > or = 160 mm Hg and diastolic blood pressure < 90 mm Hg. One hundred seventy-one control subjects had the same criteria except systolic blood pressures were < 160 mm Hg.

Effect of sample storage on quantitation of lipoprotein(a) by an enzyme-linked immunosorbent assay.

This study evaluated the effect of storage on the quantitation of lipoprotein (Lp)(a) in 25 serum samples. Aliquots of serum were stored for up to three years at either -20 degrees C or -70 degrees C and Lp(a) subsequently analyzed using an enzyme-linked immunosorbent assay kit. Concentrations of Lp(a) declined during storage, and the temperatures employed elicited significantly different (P < 0.

Communication during the recruitment phase of a multicenter trial: the recruitment hotline.

The Bypass Angioplasty Revascularization Investigation (BARI) is a randomized trial that compares the safety and efficacy of angioplasty and bypass surgery in selected patients with multivessel coronary disease. During recruitment, the Clinical Coordinating Center (CC) required an organized manner of responding to the many questions expected from the 18 clinical sites. Thus a dedicated telephone line was established to provide the clinical sites with information quickly and ensure consistent dissemination of information.

Contemporary practice of coronary revascularization in U.S. hospitals and hospitals participating in the bypass angioplasty revascularization investigation (BARI).

Objectives: To assess generalizability of the Bypass Angioplasty Revascularization Investigation (BARI), we conducted a separate study comparing revascularization in U.S. and BARI hospitals.

Risk factors for abdominal aortic aneurysms in older adults enrolled in The Cardiovascular Health Study.

B-mode ultrasound examinations of the abdominal aorta were performed from 1990 to 1992 to evaluate the prevalence of abdominal aortic aneurysm (AAA) in a subgroup of the Pittsburgh cohort (656 participants, aged 65 to 90 years) of the Cardiovascular Health Study (CHS). In this pilot study, we evaluated various definitions of aneurysm and the reproducibility of the measurements. In year 5 (1992 to 1993) of the CHS, the entire cohort (4741 participants) was examined.

Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: a multicenter clinical trial.

Efficient communication is a challenge for the many operating components of a multicenter randomized clinical trial. Traditional management theory states that communications generally flow along a path established by a hierarchical organizational structure. A multicenter clinical trial does not fit traditional organizational models well and requires modification of traditional communication techniques.

Lipoprotein(a) and peripheral atherosclerosis in older adults.

As part of an ancillary study to the Systolic Hypertension in the Elderly Program, carotid and lower extremity arterial disease (LEAD) were evaluated in 369 subjects, 186 with a systolic blood pressure (SBP) > or = 160 mmHg, and 183 with SBP < 160 mmHg. Both groups had a diastolic blood pressure (DBP) < 90 mmHg. Internal carotid stenosis was identified by Doppler and LEAD was assessed using the ankle to arm systolic blood pressure ratio, commonly called the ankle/arm index (AAI).

Carotid atherosclerosis in women with polycystic ovary syndrome: initial results from a case-control study.

Objective: Our purpose was to determine whether women with polycystic ovary syndrome have greater subclinical atherosclerosis as measured by carotid artery ultrasonography.

Study Design: Sixteen premenopausal women > or = 40 years old with a history of clinical polycystic ovary syndrome and a current total testosterone concentration > or = 2.0 nmol/L and 16 age-matched (+/- 5 years) cycling women underwent carotid scanning.

Development of risk factors for cardiovascular disease among women from adolescence to older ages.

The development of risk factors for young adults to older ages for women has been evaluated in several studies. The increase in risk factor levels is related to age, weight gain, and diet. The levels of risk factors are related to extent of atherosclerosis, even at relatively young ages.

Morbidity, mortality, and antihypertensive treatment effects by extent of atherosclerosis in older adults with isolated systolic hypertension.

Background And Purpose: The Systolic Hypertension in the Elderly Program (SHEP) demonstrated a significant reduction in stroke and coronary event rates among participants randomly assigned to active blood pressure treatment. Selected participants were evaluated for peripheral atherosclerosis and followed up for cardiovascular events beyond the end of the SHEP trial. Antihypertensive treatment effects were evaluated based on the presence or absence of clinical or subclinical atherosclerosis.

Bypass Angioplasty Revascularization Investigation (BARI): baseline clinical and angiographic data.

This report presents baseline clinical and angiographic data from the Bypass Angioplasty Revascularization Investigation (BARI), a multicenter international trial assessing the relative efficacy of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG) in selected patients with multivessel coronary artery disease. PTCA is commonly performed in patients with multivessel coronary artery disease, yet its long-term efficacy in comparison to CABG is unknown. From August 1988 through August 1991, 1,829 qualifying patients with multivessel disease suitable for either procedure were randomized to PTCA or CABG; sample size estimates were based on anticipated 5-year mortality.

Old age does not negate good cerebral outcome after cardiopulmonary resuscitation: analyses from the brain resuscitation clinical trials. The Brain Resuscitation Clinical Trial I and II Study Groups.

Objective: To assess survival after cardiac arrest and to determine whether age is an independent determinant of late mortality or poor neurologic outcome.

Design: Analyses using results of Brain Resuscitation Clinical Trial I (1979 to 1984) and Brain Resuscitation Clinical Trial II (1984 to 1989), two randomized, double-blind studies of outcome following cardiac arrest.

Setting: A multicenter study in 12 acute care hospitals in nine countries (Brain Resuscitation Clinical Trial I), and 24 hospitals in eight countries (Brain Resuscitation Clinical Trial II).

Causes, implications, and treatment of systolic hypertension.

Mild hypertension is currently defined as systolic blood pressure between 140 and 160 mm Hg. The prevalence of systolic hypertension (including this mild category) in individuals 65 and older is 21% for men and 23% for women. Risk factors include obesity, excessive sodium and alcohol consumption, and possibly calcium and bone metabolism.

Assessment of neurological prognosis in comatose survivors of cardiac arrest. BRCT I Study Group.

When a patient resuscitated from cardiac arrest remains unconscious the clinician would like to have a reliable early method for predicting the outcome. The objective of our study was to predict cerebral outcome after cardiac arrest by clinical neurological examination. The data were drawn from an international multicentre controlled clinical trial of thiopentone.

Blood pressure treatment slows the progression of carotid stenosis in patients with isolated systolic hypertension.

Background And Purpose: The Systolic Hypertension in the Elderly Program (SHEP) was a randomized trial testing the efficacy of treating systolic hypertension in older adults. A significant reduction in stroke risk was observed among participants assigned to active treatment. Serial carotid duplex scans were performed on 129 participants at the University of Pittsburgh center, and rates of progression and regression of carotid stenosis were observed.

Morbidity and mortality in hypertensive adults with a low ankle/arm blood pressure index.

Objective: To evaluate the relationship between the ankle/arm blood pressure index (AAI, the ratio of ankle to arm systolic blood pressure, a measure of peripheral arterial disease) and short-term cardiovascular morbidity and mortality in older adults with systolic hypertension.

Design: Prospective cohort study, 1- to 2-year follow-up (mean, 16 months).

Setting: Eleven of 16 field centers from the Systolic Hypertension in the Elderly Program.

Lower-extremity arterial disease in older hypertensive adults.

Lower-extremity arterial disease (LEAD) is common in older adults, particularly those with systolic hypertension. In a subgroup of 1,775 participants of the Systolic Hypertension in the Elderly Program, LEAD was assessed noninvasively by the ratio of the ankle to arm blood pressure, the ankle-arm index (AAI). LEAD was defined as an AAI of < or = 0.

Predictors of carotid stenosis in older adults with and without isolated systolic hypertension.

Background And Purpose: This study was designed to determine the prevalence of carotid stenosis and atherosclerosis in older adults with and without isolated systolic hypertension and to determine risk factors for carotid artery disease in these two groups.

Methods: Duplex scans were performed on 187 participants of the Systolic Hypertension in the Elderly Program and on 187 normotensive control subjects. Doppler measures of blood flow velocity were used to determine the prevalence of internal carotid artery stenosis.

Simpson's paradox and clinical trials: what you find is not necessarily what you prove.

Expensive clinical trials have become the gold standard for evaluating the efficacy of promising new therapeutic agents. Full exploration of the collected data is routine to maximize the yield of the information available. However, potential methodologic flaws in these extensive analyses may not be appreciated by investigators or readers.

Measurement variability in duplex scan assessment of carotid atherosclerosis.

Background And Purpose: The reproducibility of duplex scan measures of carotid atherosclerosis was evaluated as part of a study assessing the prevalence of carotid disease in elderly adults.

Methods: Doppler measures of blood flow velocity were used to evaluate disease severity, and extent of carotid plaque was scored from the B-mode image. A reader assigned a grade from 0 to 3 to each of seven segments in the carotid system, based on the number and size of lesions present.

Risk monitoring of randomized trials in emergency medicine: experience of the Brain Resuscitation Clinical Trial II.

Risk monitoring for the Brain Resuscitation Clinical Trial II, a multicenter, placebo-controlled trial to evaluate the efficacy of the calcium-entry blocker lidoflazine in the amelioration of brain damage in comatose cardiac-arrest survivors, posed unexpected challenges. Concern arose when monitoring of adverse reactions showed an excess of dangerous cardiac arrhythmias, including rearrest, in the lidoflazine group. To ascertain the cause of this problem and determine whether it was ethical for the trial to continue, an in-depth review of data was conducted, outside experts were consulted, and additional data were collected.

Lower extremity arterial disease in elderly subjects with systolic hypertension.

The ratio of ankle-to-arm systolic blood pressure (ankle/arm index or AAI) appears to be a non-invasive indicator of flow-significant atherosclerosis and may be a useful measure of burden of disease in a high risk population. The prevalence of lower extremity arterial disease (LEAD) was assessed by this method in the Systolic Hypertension in the Elderly Program (SHEP). Subjects were aged 60 and older with systolic blood pressure greater than 160 mmHg upon entry to the study.

Glucocorticoid treatment does not improve neurological recovery following cardiac arrest. Brain Resuscitation Clinical Trial I Study Group.

Glucocorticoids are commonly given to patients with global brain ischemia, although their efficacy has not been proved. The database of the Brain Resuscitation Clinical Trial I, a multi-institutional study designed to evaluate the effect of thiopental sodium therapy on neurological outcome following brain ischemia, was used for a retrospective review of the effects of glucocorticoid treatment on neurological outcome after global brain ischemia. This study included 262 initially comatose cardiac arrest survivors who made no purposeful response to pain after restoration of spontaneous circulation.

Predictors of electromechanical dissociation during cardiac arrest.

ECG patterns observed during cardiac arrest were analyzed in 261 comatose cardiac arrest survivors. Forty-seven patients (18%) exhibited electromechanical dissociation (EMD) at some point before restoration of stable spontaneous circulation. These patients had a higher mortality (P = .