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The RECOVER IV Trial (RECOVER IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05506449
Recruitment Status : Recruiting
First Posted : August 18, 2022
Last Update Posted : January 24, 2024
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

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.

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction (STEMI) Cardiogenic Shock Device: Impella CP® Other: Standard of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multicenter, randomized, controlled, open-label two-arm trial with an adaptive design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Impella® Support in Patients With ST-Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock: The RECOVER IV Trial
Actual Study Start Date : October 28, 2023
Estimated Primary Completion Date : April 30, 2026
Estimated Study Completion Date : December 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

Arm Intervention/treatment
Active Comparator: Control Arm
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.
Other: Standard of Care
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.

Experimental: Treatment Arm
Subjects randomized to the Treatment Arm will receive hemodynamic support using an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI).
Device: Impella CP®

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.





Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [ Time Frame: 30 Days ]
  2. Days Alive Out-of-Hospital [ Time Frame: 6 Months ]
  3. Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire [ Time Frame: 1 Year ]

Other Outcome Measures:
  1. All-Cause Mortality [ Time Frame: At hemodynamic stability and when the subject is no longer hospitalized, 6 Months, 1 Year ]
  2. MACCE [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 6 Months, 1 Year ]
  3. Days Alive Out-of-Hospital [ Time Frame: 30 Days, 6 Months ]
  4. Mean Change in Health-Related Quality of Life, as measured by Kansas City Cardiomyopathy Questionnaire [ Time Frame: 30 Days Post-Discharge, 6 Months ]
  5. Mean Change in Health-Related Quality of Life, as measured by Rose Dyspnea Score [ Time Frame: 30 Days Post-Discharge, 6 Months, 1 Year ]
  6. Mean Change in Health-Related Quality of Life, as measured by EQ-5D-5L [ Time Frame: 30 Days Post-Discharge, 6 Months, 1 Year ]
  7. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 30 Days, 6 Months ]
  8. Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
  9. Number of Participants with need for In-Hospital Hemodialysis or Continuous Renal Replacement Therapy (CRRT) [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
  10. Number of Participants with need for Dialysis Post-Index Hospitalization [ Time Frame: 30 Days, 6 Months, 1 Year ]
  11. Number of Participants with any Dialysis [ Time Frame: 30 Days, 6 Months, 1 Year ]
  12. All-Cause Hospitalizations [ Time Frame: 30 Days, 6 Months, 1 Year ]
  13. Cardiovascular Hospitalizations [ Time Frame: 30 Days, 6 Months, 1 Year ]
  14. Heart Failure Hospitalizations [ Time Frame: 30 Days, 6 Months, 1 Year ]
  15. Number of Participants with new Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) Implant [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
  16. Number of Participants with Left Ventricular Assist Device (LVAD) or Heart Transplant (including United Network for Organ Sharing (UNOS) 1/2 listing) [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
  17. Repeat Target Vessel Revascularization (TVR) [ Time Frame: 30 Days, 6 Months, 1 Year ]
  18. Acute Kidney Injury (AKI) [ Time Frame: within 7 Days Post-Percutaneous Coronary Intervention (PCI) ]
  19. Disability Assessed using the Modified Rankin Scale [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized, 30 Days, 6 Months, 1 Year ]
  20. 30-day survival with mRS score ≤3 [ Time Frame: 30 day ]
  21. Number of Participants with Neurologic Academic Research Consortium (NeuroARC) Type 1 Stroke [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
  22. Major Bleeding [ Time Frame: Shock Academic Research Consortium (SHARC) Types 3-5, At hemodynamic stability when the subject is no longer hospitalized ]
  23. Major Vascular Complications [ Time Frame: SHARC Definition, At hemodynamic stability when the subject is no longer hospitalized ]
  24. Major Hemolysis [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
  25. Major Cath Lab Complications [ Time Frame: All adverse events will be recorded and documented through 1 year follow up or study completion ]
    Intubation; new bradyarrhythmia requiring a temporary pacemaker; ventricular arrhythmias requiring cardioversion or defibrillation; persistent severe hypotension or heart failure requiring escalation beyond the randomized study devices (Impella CP in the Treatment Arm and intra-aortic balloon pump (IABP) in the Control Arm).

  26. All Stroke [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
  27. Minor Bleeding [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
  28. Minor Vascular Complications [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]
  29. Minor Hemolysis [ Time Frame: At hemodynamic stability when the subject is no longer hospitalized ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cardiogenic shock with onset ≤12 hours after STEMI and prior to index PCI, as defined by having both the following:

    1. Persistent SBP <90 mmHg for ≥30 minutes despite fluid resuscitation or pressors/inotropes required to maintain SBP ≥90 mmHg and
    2. Signs of impaired organ perfusion (cool extremities and/or altered mental status)
  2. One of the following must be present on a standard 12-lead electrocardiogram (ECG):

    1. ST-segment elevation (≥2 mm elevation of ST-segments in ≥2 contiguous leads without left bundle branch block) or
    2. 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
    3. 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.
  3. Intended emergent PCI to treat the STEMI
  4. 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:

  1. High suspicion for isolated right ventricular infarct confirmed with ECG lead V4R
  2. Cardiogenic shock with either of the following:

    1. 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
    2. Isolated narrow complex supraventricular tachycardia with ventricular response >170 bpm or ventricular tachyarrhythmia with ventricular response >150 bpm
  3. 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
  4. 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)
  5. 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.
  6. IABP, Impella or other mechanical circulatory support already in place for present indication (pre-randomization)
  7. Known end-stage renal disease, receiving dialysis
  8. 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
  9. Acute or chronic aortic dissection, if known
  10. Large or mobile LV thrombus, if known
  11. Prior PCI for the present infarction
  12. Prior PCI or coronary artery bypass graft (CABG) within 1 year, if known
  13. Ongoing cardiopulmonary resuscitation (CPR)
  14. 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:

      1. They did not have a cardiac arrest and were following verbal commands prior to intubation or
      2. They are clearly following verbal commands after intubation
  15. Prior stroke with permanent, significant neurological defect
  16. Prior intracranial hemorrhage or known intracerebral mass, aneurysm or fistula
  17. Acute or suspected stroke prior to randomization
  18. Active infection requiring oral or intravenous antibiotics
  19. Prior heparin-induced thrombocytopenia, if known
  20. Other severe, concomitant disease with limited life expectancy <1 year (other than cardiogenic shock)
  21. Pregnancy, known or suspected
  22. 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
  23. 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
  24. 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)
  25. 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]
  26. Patient is wearing a bracelet or other item indicating their wishes to decline participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05506449


Contacts
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Contact: Sameera Dasari, PhD 978-914-8882 sdasari@abiomed.com

Locations
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United States, Arizona
Dignity Health Chandler Regional Medical Center Not yet recruiting
Gilbert, Arizona, United States, 85297
Principal Investigator: Nabil Dib         
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Haval Chweich, MD         
United States, Michigan
Henry Ford Health System Not yet recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Mir B Basir, DO         
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Haroon Faraz         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Principal Investigator: Mark Bieniarz         
Presbyterian Healthcare Services Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Principal Investigator: Robert Federici, MD         
United States, Pennsylvania
Allegheny General Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
Principal Investigator: David Lasorda         
UPMC Presbyterian Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Jeffrey Fowler         
Germany
Herzzentrum Dresden Not yet recruiting
Dresden, Saxony, Germany, 01307
Principal Investigator: Norman Mangner         
Sponsors and Collaborators
Abiomed Inc.
Investigators
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Principal Investigator: Navin Kapur, MD Tufts Medical Center
Principal Investigator: William O'Neill, MD Henry Ford Health System
Study Chair: Gregg Stone, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT05506449    
Other Study ID Numbers: ABMD-CIP-22-02
First Posted: August 18, 2022    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Abiomed Inc.:
Cardiovascular Diseases
Myocardial Infarction
Heart Failure
Exception From Informed Consent (EFIC)
Cardiogenic Shock
Additional relevant MeSH terms:
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Myocardial Infarction
Shock, Cardiogenic
ST Elevation Myocardial Infarction
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases