The primary goal of the Heart and Soul Study was to determine why depression is associated with an increased risk of cardiovascular events in outpatients with stable coronary heart disease.25 (link) We used administrative databases to identify outpatients with documented coronary artery disease at 2 Department of Veterans Affairs Medical Centers (San Francisco VA Medical Center and the VA Palo Alto Health Care System, California), 1 university medical center (University of California, San Francisco), and 9 public health clinics in the Community Health Network of San Francisco.
Patients were eligible to participate if they had at least 1 of the following: a history of myocardial infarction, angiographic evidence of at least 50% stenosis in 1 or more coronary vessels, prior evidence of exercise-induced ischemia by treadmill or nuclear testing, a history of coronary revascularization, or a diagnosis of coronary artery disease documented by an internist or cardiologist. Between September 11, 2000, and December 20, 2002, a total of 1024 participants were enrolled: 240 from the public health clinics, 346 from the university medical center, and 438 from the VA medical centers.
All participants completed a baseline examination that included an interview, fasting blood draw, psychiatric interview, questionnaire, echocardiogram, exercise treadmill test, 24-hour ambulatory electrocardiogram, and 24-hour urine collection. Of the 1024 participants who completed the baseline examination, we were not able to contact 7 (<1%) during the follow-up period, leaving 1017 for this analysis. Our protocol was approved by the appropriate institutional review boards, and all participants provided written informed consent.