What side effects are associated with this type of intervention?

Common treatments for heart attack that provide hemodynamic support, such as the Impella device, include intra-aortic balloon counterpulsation and the use of vasopressors like norepinephrine. Intra-aortic balloon counterpulsation can lead to complications such as vascular injury, bleeding, and infection. Vasopressors, particularly norepinephrine, are associated with side effects including arrhythmias, ischemia, and increased risk of mortality compared to other agents like dopamine. These treatments aim to stabilize hemodynamics but come with significant risks that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for heart attacks, focusing on restoring blood flow and supporting heart function. These include thrombolytic agents like alteplase, anticoagulants such as heparin, and antiplatelet drugs like aspirin and clopidogrel. For hemodynamic support, devices like the Impella, which provides mechanical circulatory support, have been approved to assist patients in cardiogenic shock following a heart attack. The Impella device helps maintain cardiac output and stabilize patients before or after percutaneous coronary intervention (PCI).

What other types of research exist?

Promising alternatives to the Impella device for hemodynamic support in heart attack patients include: 1) The use of extracorporeal membrane oxygenation (ECMO) for temporary cardiac and respiratory support. 2) The development of advanced left ventricular assist devices (LVADs) that are smaller and more efficient. 3) Novel pharmacological agents such as cardiac myosin activators (e.g., omecamtiv mecarbil) that enhance cardiac contractility. 4) Enhanced percutaneous ventricular assist devices (pVADs) that offer improved ease of use and patient outcomes.

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Mechanical Circulatory Support Device

Impella CP® for Heart Attack and Cardiogenic Shock (RECOVER IV Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for heart attacks aim to restore blood flow to the heart muscle, reduce the heart's workload, and prevent further clot formation. Thrombolytic agents dissolve existing clots, while percutaneous coronary intervention (PCI) mechanically opens blocked arteries. Antiplatelet drugs and anticoagulants prevent new clots from forming. Beta-blockers and ACE inhibitors reduce the heart's workload and oxygen demand. The Impella device, a form of hemodynamic support, assists the heart in pumping blood, thereby stabilizing patients and improving outcomes. These treatments are crucial as they minimize heart muscle damage, improve survival rates, and enhance recovery.

N/A

Waitlist Available

Led By Navin Kapur, MD

Research Sponsored by Abiomed Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiogenic shock with onset ≤12 hours after STEMI and prior to index PCI, as defined by having 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)

Presence of 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

Must not have

Known end-stage renal disease, receiving dialysis

Prior PCI or coronary artery bypass graft (CABG) within 1 year, if known

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all adverse events will be recorded and documented through 1 year follow up or study completion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using an Impella device to help the heart pump blood before opening blocked arteries improves survival in patients with severe heart attacks and heart failure. The Impella device temporarily assists the heart, allowing it to rest while maintaining blood flow. The goal is to see if this approach reduces deaths compared to other treatments. The Impella device has been shown to improve blood flow in the heart and is used as a last-resort treatment in patients with severe heart conditions.

Who is the study for?

The RECOVER IV Trial is for patients who've had a severe type of heart attack (STEMI) leading to cardiogenic shock within the last 12 hours. They must be planning to undergo an emergency procedure to open blocked arteries (PCI), have low blood pressure despite treatment, and show signs of poor blood flow to organs. Excluded are those with certain medical conditions like prior strokes, severe infections, or life expectancy less than a year.

What is being tested?

This trial tests if starting Impella CP® support before opening blocked arteries in the heart improves survival and recovery compared to standard treatments without Impella. Patients with STEMI-cardiogenic shock will either receive this device-based strategy or continue with usual care methods before their PCI procedure.

What are the potential side effects?

Potential side effects from using Impella CP® include bleeding complications, issues related to vascular access such as infection or limb ischemia, possible stroke risk due to clots forming on the device, and general risks associated with heart procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experienced a severe heart condition shortly after a heart attack, needing medication to maintain my blood pressure.

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I have specific heart attack signs on an EKG and a confirmed blockage in my heart's arteries.

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I am scheduled for an emergency procedure to treat a severe heart attack.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe kidney failure and am on dialysis.

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I had a heart stent or bypass surgery within the last year.

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I have severe aortic valve issues or have had a valve replacement.

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I have a large or moving blood clot in my heart.

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I have heart complications from a recent heart attack that could lead to shock.

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I am currently on antibiotics for an infection.

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I am currently receiving CPR.

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I have had a stroke that left me with lasting significant neurological issues.

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I cannot follow spoken instructions after a cardiac arrest.

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I have had a stent placed for my current heart attack.

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I have had a brain bleed or have a known brain mass, aneurysm, or abnormal connection between blood vessels.

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I have a fast heart rate due to a specific type of irregular heartbeat.

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I have severe artery disease in both legs preventing certain heart support device insertions.

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I have a known aortic dissection.

Select...

I do not have a severe illness that would limit my life to less than a year.

Select...

I have had a stroke or doctors think I might have had one recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all adverse events will be recorded and documented through 1 year follow up or study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all adverse events will be recorded and documented through 1 year follow up or study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and all adverse events will be recorded and documented through 1 year follow up or study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Major Cath Lab Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment1 Intervention

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

Group II: Control ArmActive Control1 Intervention

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.

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart attacks aim to restore blood flow to the heart muscle, reduce the heart's workload, and prevent further clot formation. Thrombolytic agents dissolve existing clots, while percutaneous coronary intervention (PCI) mechanically opens blocked arteries. Antiplatelet drugs and anticoagulants prevent new clots from forming. Beta-blockers and ACE inhibitors reduce the heart's workload and oxygen demand. The Impella device, a form of hemodynamic support, assists the heart in pumping blood, thereby stabilizing patients and improving outcomes. These treatments are crucial as they minimize heart muscle damage, improve survival rates, and enhance recovery.