Methods and Preliminary Results of Implementation of Multi-Center Earlyimpella® Support in Patients with St-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock (RECOVER IV) Trial Under Exception from Informed Consent

Document Type

Conference Proceeding

Publication Date

4-1-2024

Publication Title

J Heart Lung Transplant

Abstract

Purpose: Cardiogenic shock (CS) is end-organ hypoperfusion due to reduced cardiac output (CO). ~50% of patients with CS and acute myocardial infarction die before discharge. Drugs or devices can improve CO. We do not know if temporary mechanical circulatory support (MCS) improves long-term survival. Few trials have enrolled patients with CS in the United States (US) in part due to difficulties obtaining informed consent. The prognosis of patients with CS who are able to consent for research differs from those who are not, so consent-based trials may bias estimates of treatment. Exception from informed consent (EFIC) for emergency research is allowed in the US if certain conditions are met a priori. Prior EFIC studies required more than nine months to meet these conditions due to local site variation in implementation. We are implementing and evaluating a centralized, standardized EFIC framework in the RECOVER IV trial of standard care with Impella (Abiomed, Danvers, MA) MCS vs. standard care alone in patients who present with CS. Methods: Over five years, 560 patients (280 per group) will be randomized to intervention (Impella and standard care) vs. control for 90% power to detect a 13.5% difference in 30-day survival. Community consultation (CC) and public disclosure (PD) in candidate sites is required before starting enrollment. CC seeks community feedback about the study. PD gives information about the study for transparency and trustworthiness. We will centrally-coordinate CC and PD across up to 40 US sites, with localized study-specific websites, social media, focus groups, community events, radio ads, print media, and a single IRB to increase efficiency of site start up. Participants enrolled under EFIC will be notified of enrollment as soon as feasible, and consent will be sought for ongoing participation. Ten European sites will enroll patients using deferred consent. Results: The first site to complete CC and PD required three months from initiation of activities to IRB approval using our centralized framework. Conclusion: Effectively studying interventions in patients with CS requires EFIC in the US. Centrally-coordinated EFIC may improve the efficiency of study initiation to facilitate rapid advancement of evidence-based care.

Volume

43

Issue

4

First Page

S126

Last Page

S127

Find It @ Sladen

Share

COinS