Digital assessment of the epicardial electrocardiogram: novel methodology for a core laboratory for clinical studies.

Background: The epicardial electrocardiogram (ECG) is a sensitive marker for cardiac ischemia and has been used as a measure of ischemia in clinical trials. We sought to examine the utility of a central ECG laboratory for determining ischemic-type ST-segment shifts from epicardial ECG recordings obtained from multiple clinical sites.

Hypothesis: We speculated that an operator-assisted digital ECG core laboratory is feasible, reliable, and efficient, with the ability for rapid and accurate interpretation of the epicardial ECG.

Rationale and design of the International Verapamil SR/Trandolapril Study (INVEST): an Internet-based randomized trial in coronary artery disease patients with hypertension.

Objectives: The primary objective of the International Verapamil SR/Trandolapril Study (INVEST) is to compare the risk for adverse outcomes (all-cause mortality, nonfatal myocardial infarction [MI] or nonfatal stroke) in hypertensive patients with coronary artery disease (CAD) treated with either a calcium antagonist-based or a noncalcium antagonist-based strategy.

Background: Treatment recommendations for hypertension include initial therapy with a diuretic or beta-adrenergic blocking agent, for which reductions in morbidity and mortality are documented from randomized trials but are less than expected from epidemiologic data. For this reason, recent attention has focused on calcium antagonists or angiotensin-converting enzyme inhibitors.

Identifying high yield sources of patients with coronary artery disease for clinical trials: lessons from the Asymptomatic Cardiac Ischemia Pilot (ACIP) experience. The ACIP Study Group.

Background And Hypothesis: Successful recruitment strategies for ischemic heart disease (IHD) clinical trials must identify high yield sources and efficient methods for selecting patients likely to have coronary artery disease (CAD) and ischemia, but such information is lacking.

Methods: Data from the recently completed Asymptomatic Cardiac Ischemia Pilot (ACIP) Trial were used as a model contemporary CAD/IHD trial to determine the relative patient yields, within a specific time frame, for various recruitment sources.

Results: Over 15 months, a total of 88,881 patient records was screened at 10 sites.

Plasma volume changes with an acute bout of high-intensity exercise in men with chronic congestive heart failure secondary to coronary artery disease.

We assessed plasma volume changes at peak exercise in 17 nonedematous men with chronic congestive heart failure due to coronary artery disease. Our findings suggest that acute exercise is associated with transient decreases in plasma and blood volume in these patients, similar in magnitude to those reported for healthy adults at peak exercise.

Effects of intermittent transdermal nitroglycerin on occurrence of ischemia after patch removal: results of the second transdermal intermittent dosing evaluation study (TIDES-II).

Objectives: We sought to evaluate the effects of intermittent transdermal nitroglycerin (TD-NTG) on the occurrence of ischemia during patch-off hours in patients with stable angina pectoris receiving a beta-adrenergic blocking agent or calcium antagonist, or both.

Background: The current recommendations for the use of intermittent TD-NTG may be associated with the occurrence of rebound ischemia.

Methods: This was a multicenter, randomized, double-blind, placebo-controlled, crossover trial with three study periods.