The RECOVER IV Trial

Stopped early · Not applicable

Conditions studied: ST-segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock

In brief

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.

Key facts

Study ID

NCT05506449

Run by

Abiomed Inc.

People needed

4

Starts

2023-10-28

Expected to finish

2024-12-06

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Severe aortic stenosis, or moderate or worse aortic regurgitation or prior self-expanding transcatheter aortic valve replacement (TAVR), or surgically placed mechanical valve, if known
• Acute or chronic aortic dissection, if known
• Large or mobile LV thrombus, if known
• Prior PCI for the present infarction
• Prior PCI or coronary artery bypass graft (CABG) within 1 year, if known
• Ongoing cardiopulmonary resuscitation (CPR)
• Not obeying verbal commands after preadmission or in-hospital cardiac arrest
• NOTE: (i) A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice (ii) Intubated subjects may be enrolled if:
• They did not have a cardiac arrest and were following verbal commands prior to intubation or
• They are clearly following verbal commands after intubation
• Prior stroke with permanent, significant neurological defect
• Prior intracranial hemorrhage or known intracerebral mass, aneurysm or fistula
• Acute or suspected stroke prior to randomization
• Active infection requiring oral or intravenous antibiotics
• Prior heparin-induced thrombocytopenia, if known

Where it is running

• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Rigshospitalet Copenhagen — Copenhagen, Denmark
• Herzzentrum Dresden — Dresden, Saxony, Germany
• University Hospital Düsseldorf — Düsseldorf, Germany
• Universitatsklinikum Schleswig Holstein — Kiel, Germany
• Krankenhaus der Barmherzigen Brüder Trier — Trier, Germany
• Inselspital Bern — Bern, Switzerland

Full record on ClinicalTrials.gov

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