Early Impella® Support in Patients With ST-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock: The RECOVER IV Trial

Abiomed Inc.7 sites in 4 countries4 target enrollmentOctober 28, 2023

ConditionsST-segment Elevation Myocardial Infarction (STEMI)Cardiogenic Shock

Overview

Phase: N/A
Intervention: Not specified
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Sponsor: Abiomed Inc.
Enrollment: 4
Locations: 7
Primary Endpoint: All-Cause Mortality
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess whether hemodynamic support with an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI) in patients with ST-Segment Elevation Myocardial Infarction (STEMI)-Cardiogenic Shock (CS) improves survival and functional outcomes compared to a non-Impella-based treatment strategy.

Detailed Description

To demonstrate that hemodynamic support with an Impella-based treatment strategy initiated prior to PCI, when compared with a non-Impella-based standard of care treatment strategy reduces all-cause mortality at 30 days in patients with STEMI-CS.

Registry

clinicaltrials.gov

Start Date

October 28, 2023

End Date

December 6, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abiomed Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cardiogenic shock with onset ≤12 hours after STEMI and prior to index PCI, as defined by having both the following:
•Persistent SBP \<90 mmHg for ≥30 minutes despite fluid resuscitation or pressors/inotropes required to maintain SBP ≥90 mmHg and
•Signs of impaired organ perfusion (cool extremities and/or altered mental status)
•One of the following must be present on a standard 12-lead electrocardiogram (ECG):
•ST-segment elevation (≥2 mm elevation of ST-segments in ≥2 contiguous leads without left bundle branch block) or
•Anterior (V1-V4) ST-segment depression ≥2 mm in ≥2 contiguous leads consistent with a possible posterior infarction AND coronary angiogram prior to randomization showing acute total or subtotal occlusion of the proximal circumflex artery or
•aVR ST-segment elevation ≥2 mm without anterior ST-segment elevation AND coronary angiogram prior to randomization confirming left main culprit lesion
•NOTE: Patients with isolated RV infarction are excluded from this Protocol. If a patient qualifies with cardiogenic shock with only inferior ST-segment elevation, pre-randomization assessment of LV function must be obtained with either point of care echocardiography or contrast left ventriculography to demonstrate a LVEF ≤40% for the patient to be eligible for randomization.
•Intended emergent PCI to treat the STEMI
•Subject is able to and agrees to provide written informed consent. If the subject is unable to be consented because of their extreme illness and a legally authorized representative (LAR) is present, the LAR must agree and provide written informed consent. If the subject is unable to provide consent because of their extreme illness and an LAR is not present, the patient may be randomized under Exception from Informed Consent (EFIC) Guidance

Exclusion Criteria

•High suspicion for isolated right ventricular infarct confirmed with ECG lead V4R
•Cardiogenic shock with either of the following:
•High-grade atrioventricular block (heart rate (HR) \<50 bpm)
•NOTE: If patient is paced, via temporary or permanent pacemaker, and still in shock, they are still eligible
•Isolated narrow complex supraventricular tachycardia with ventricular response \>170 bpm or ventricular tachyarrhythmia with ventricular response \>150 bpm
•Known mechanical complications of acute myocardial infarction (AMI) that may cause cardiogenic shock such as free wall rupture, cardiac tamponade, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation
•Left ventricular function (LVEF \>40%) on echocardiography or LV-gram (if performed) indicating shock due to another cause (e.g., RV infarction as the principal cause of shock, hypovolemia, sepsis or high cardiac output shock)
•Severe bilateral peripheral arterial disease precluding femoral Impella CP insertion (femoral angiogram required) NOTE: Impella insertion via a non-femoral arterial route is not permitted in this Protocol.
•IABP, Impella or other mechanical circulatory support already in place for present indication (pre-randomization)
•Known end-stage renal disease, receiving dialysis

Outcomes

Primary Outcomes

All-Cause Mortality

Time Frame: 30 Days

Secondary Outcomes

Days Alive Out-of-Hospital(6 Months)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(30 Days)
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire(1 Year)