REGARDS is a prospective cohort study of 30 239 individuals examining regional and racial influences on stroke mortality. Details are described elsewhere15 (link)–16 (link); briefly, participants were enrolled between 2003 and 2007 using commercially available lists and a combination of mail and telephone contacts to recruit English-speaking, community-dwelling adults aged 45 years or older, who were living in the continental United States. Race and sex were balanced by design, with oversampling from the Southeastern United States; the final cohort included 58% of participants who were women and 42% of participants who had black race. Race was self-reported. Baseline data collection included computer-assisted telephone surveys assessing medical history and health status. In-home examinations by trained health care professionals followed standardized, quality-controlled protocols to collect fasting blood and urine samples; electrocardiograms; blood pressure, height, and weight measurements; and medication use by pill bottle review. Blood and urine samples were centrally analyzed at the University of Vermont. Electrocardiograms were centrally analyzed at Wake Forest University.
Living participants or their proxies were followed up every 6 months by telephone with retrieval of medical records for reported hospitalizations. Deaths were detected by report of next of kin or through online sources (eg, Social Security Death Index) and the National Death Index. Proxies or next of kin were interviewed about the circumstances surrounding death, including the presence of chest pain. Death certificates and autopsy reports also were obtained to adjudicate cause of death.
For this study, individuals with prevalent CHD (self-report of MI or coronary revascularization procedure at baseline or evidence of prior MI on the baseline electrocardiogram) were excluded. Events through December 31, 2009, were included in this analysis. At that time, 9.5% were lost to follow-up. The study protocol was reviewed and approved by the institutional review boards at the participating institutions and all participants provided informed consent.
Living participants or their proxies were followed up every 6 months by telephone with retrieval of medical records for reported hospitalizations. Deaths were detected by report of next of kin or through online sources (eg, Social Security Death Index) and the National Death Index. Proxies or next of kin were interviewed about the circumstances surrounding death, including the presence of chest pain. Death certificates and autopsy reports also were obtained to adjudicate cause of death.
For this study, individuals with prevalent CHD (self-report of MI or coronary revascularization procedure at baseline or evidence of prior MI on the baseline electrocardiogram) were excluded. Events through December 31, 2009, were included in this analysis. At that time, 9.5% were lost to follow-up. The study protocol was reviewed and approved by the institutional review boards at the participating institutions and all participants provided informed consent.