TerminatedNot Applicable

The RECOVER IV Trial

Stopped: Given the findings from the DanGer Shock RCT, the RECOVER IV independent DSMB believes that equipoise for randomization in the RECOVER IV Trial no longer exists and has recommended that the RECOVER IV Trial be permanently discontinued.

United States, Denmark, Germany4 participantsStarted 2023-10-28

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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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
✓. Intended emergent PCI to treat the STEMI

Exclusion criteria

What they're measuring

All-Cause Mortality

Timeframe: 30 Days

Trial details

NCT IDNCT05506449

SponsorAbiomed Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-10

View on ClinicalTrials.gov More ST-segment Elevation Myocardial Infarction (STEMI) trials