![]() Reasons for involvement included wanting to be the decision maker and a desire for transparency. Across scenarios, most participants (73%-80%) preferred to be asked permission prior to trial enrolment. Descriptive analysis was performed of Likert scale data, and qualitative descriptive analysis was performed of textual data. Participants were asked their desired involvement in enrolment decisions and willingness to participate. Participants considered three scenarios: (1) a CER trial of approved antiplatelet drugs (2) a placebo-controlled trial of a novel drug to reduce myocardial injury and (3) a CER trial of an intra-aortic balloon pump versus medication. Structured interviews were conducted with 30 patients with AMI. It is unknown whether this is true across trial designs or in comparative effectiveness research (CER) with approved treatments. Prior data suggest that enrolment decisions of patients are often poorly informed in AMI trials but that patients prefer to be asked permission before enrolment. ![]() Seeking prospective informed consent is difficult in clinical trials for emergent conditions such as acute myocardial infarction (AMI). Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design.ĭickert, Neal W Hendershot, Kristopher A Speight, Candace D Fehr, Alexandra E The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. A registry-based randomized clinical trial.įröbert, Ole Götberg, Matthias AngerÃ¥s, Oskar Jonasson, Lena Erlinge, David Engstrøm, Thomas Persson, Jonas Jensen, Svend E Omerovic, Elmir James, Stefan K Lagerqvist, Bo Nilsson, Johan KÃ¥regren, Amra Moer, Rasmus Yang, Cao Agus, David B Erglis, Andrejs Jensen, Lisette O Jakobsen, Lars Christiansen, Evald H Pernow, John Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. ![]()
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