A randomized multicenter trial to evaluate early invasive strategy for patients with acute ST-segment elevation myocardial infarction presenting 24-48 hours from symptom onset: Protocol of the RESCUE-MI study.

ABSTRACT

BACKGROUND: For ST-segment elevation myocardial infarction (STEMI) patients presenting 24 to 48 hours from symptom onset, whether early invasive strategy should be performed still remains controversial. METHODS: This is a prospective, open-label, multicenter, investigator initiated, randomized controlled trial (NCT04962178) to evaluate the efficacy of early invasive strategy for STEMI patients within 24 to 48 hours of symptom onset. A total of 366 patients will be included from 10 hospitals in mainland China. They will be randomly (11) divided into 2 groups the early invasive strategy group (primary percutaneous coronary intervention, PPCI) and conservative strategy group (optimal medical therapy with primary PCI not performed). All patients will be followed for 1 month. The primary end point is myocardial infarction size on cardiac magnetic resonance (CMR). The secondary end points are as follows (1) major adverse cardiovascular events (MACE), which is defined as a composite of cardiac death, recurrent myocardial infarction, ischemic driven target vessel revascularization and stroke; (2) other CMR end points, including microvascular obstruction, intramyocardial hemorrhage, myocardial area at risk, left ventricular ejection fraction, left ventricular end diastolic volume and left ventricular end systolic volume. DISCUSSION: This study is designed to evaluate the efficacy of early invasive strategy for STEMI patients within 24 to 48 hours of symptom onset and will add more evidence for clinical practice. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04962178. Registered on July 14, 2021.