New Study Questions Generalizability of Cardiovascular Trials for Heart Attack Patients

Efforts to improve clinical trial participation are needed to enhance “generalizability of results” and nesting trials within existing registries may help meet this goal,” according to a research letter published Aug. 27 in the Journal of the American Medical Association

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According to the letter’s authors, “randomized clinical trials of patients with acute myocardial infarction (MI) enroll selected populations, with low enrollment in the United States, raising questions whether findings are generalizable.”  Using data from the ACC’s ACTION Registry-Get with the Guidelines, they evaluated whether participants in cardiovascular trials are representative of contemporary patients with MI.

Overall results showed that within the ACTION Registry, trial participation was infrequent and declined during the study period. However, the authors noted that two out of three patients with MI were potentially eligible for a randomized clinical trial. Trial participants also had a lower risk profile and a more favorable prognosis compared with the broader population with MI, particularly patients eligible for but not enrolled in a clinical trial. According to the authors, common reasons for ineligibility, included uncontrolled hypertension (42 percent), elevated INR (20 percent), severe anemia (15 percent), and cardiogenic shock (14 percent).

Based on these findings, the authors suggest there may be opportunities to leverage registries to improve generalizability of clinical trial results moving forward.

Keywords: International Normalized Ratio, Prognosis, Shock, Cardiogenic, Registries, Myocardial Infarction, Hypertension, National Cardiovascular Data Registries, ACTION Registry, PINNACLE Registry

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