ST-segment Elevation Myocardial Infarction (STEMI)RECOVER IVNCT05506449
The RECOVER IV Trial
A study testing Impella CP® in people with ST-segment Elevation Myocardial Infarction (STEMI) and Cardiogenic Shock, run by Abiomed Inc. at 7 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock
- What is being tested?
- Impella CP®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 28 Oct 2023to 6 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Other severe, concomitant disease with limited life expectancy <1 year (other than cardiogenic shock)
- Pregnancy, known or suspected
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint or any cardiogenic shock trial other than a registry
- If known, subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
- Subject has other medical, social or psychological conditions that, in the opinion of the Investigator, compromises the subject's ability to comply with study procedures (e.g., dementia, severe alcohol or substance abuse)
- Patient belongs to a vulnerable population [Vulnerable patient populations may include individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]
- Patient is wearing a bracelet or other item indicating their wishes to decline participation in the study
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Germany4 sites
Herzzentrum Dresden
Dresden, Saxony, 01307
University Hospital Düsseldorf
Düsseldorf
Universitatsklinikum Schleswig Holstein
Kiel
Krankenhaus der Barmherzigen Brüder Trier
Trier
United States1 site
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
About this study
Official title: Early Impella® Support in Patients With ST-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock: The RECOVER IV Trial
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.
Read the 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.
- Being tested
- Impella CP®, Standard of Care
- Keywords
- Cardiovascular Diseases, Myocardial Infarction, Heart Failure, Exception From Informed Consent (EFIC), Cardiogenic Shock
- Medical subject headings
- ST Elevation Myocardial Infarction, Shock, Cardiogenic, Cardiovascular Diseases, Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella CP®Device
Subjects randomized to the Treatment Arm will undergo Impella CP placement prior to PCI. Right heart catheterization will be performed prior to or immediately after PCI.
Use of IABP will not be allowed in the Treatment Arm.
Standard of CareOther
This may include inotropes and/or vasopressors. An IABP may or may not be used according to local practice and the specific condition of each individual patient. If an IABP is used, it may be placed prior to or after PCI, and its timing of explant is left to the discretion of the Investigator.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Subjects randomized to the Control Arm will be treated based on recommendations for cardiogenic shock in the contemporary AHA/ACC/SCAI and ESC Practice Guidelines for STEMI and Heart Failure Management and local standard of care. Receives: Other: Standard of Care |
| Treatment Arm | Experimental | Subjects randomized to the Treatment Arm will receive hemodynamic support using an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI). Receives: Device: Impella CP® |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Measured: 30 Days
Secondary outcomes (3)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Measured: 30 Days
Days Alive Out-of-Hospital
Measured: 6 Months
Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start28 Oct 2023
- Primary completion10 May 2024
- Study completion6 Dec 2024
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, controlled, open-label two-arm trial with an adaptive design
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Navin Kapur, MD, Principal investigator, Tufts Medical CenterWilliam O'Neill, MD, Principal investigator, Henry Ford Health SystemGregg Stone, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506449
- Sponsor's protocol ID
- ABMD-CIP-22-02
- Acronym
- RECOVER IV
- Status last verified
- Jan 2025
- First submitted
- 15 Aug 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jentzer JC, Hibbert B. Optimal patient and mechanical circulatory support device selection in acute myocardial infarction cardiogenic shock. Lancet. 2024 Sep 14;404(10457):992-993. doi: 10.1016/S0140-6736(24)01588-5. Epub 2024 Sep 2. No abstract available.
PubMed 39236724