Mechanical Circulatory Support for Heart Attack

(DTU-STEMI Trial)

Recruiting at 71 trial locations

Overseen By Poornima Sood, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abiomed Inc.

Must not be taking: Anticoagulants, Steroids

Disqualifiers: Cardiogenic shock, Severe aortic stenosis, Pregnancy, Hepatic insufficiency, Renal replacement therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate

527 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the heart caused by a heart attack, compared to the current standard of care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are on systemic anticoagulation (blood thinners) before the procedure. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment IMPELLA® CP System for heart attack?

The Impella CP System, a mechanical heart pump, has shown effectiveness in providing temporary support for patients experiencing cardiogenic shock (a condition where the heart suddenly can't pump enough blood) after a heart attack. Studies indicate it offers better heart support and fewer complications compared to other devices like balloon pumps, helping patients recover while their heart heals. ^{1 2 3 4 5}

Is the Impella CP system safe for use in humans?

The Impella CP system is generally considered safe and is associated with fewer complications compared to other devices like intra-aortic balloon pumps and venoarterial extracorporeal membrane oxygenation. It has been used in various conditions, including cardiogenic shock and cardiac arrest, with a focus on providing strong heart support. ^{1 2 4 5 6}

How is the Impella CP System treatment different from other treatments for heart attack?

The Impella CP System is a unique treatment for heart attack patients experiencing cardiogenic shock because it is a small pump inserted through the skin that provides temporary support by helping the heart pump blood, offering greater hemodynamic support and fewer complications compared to other devices like intra-aortic balloon pumps and VA-ECMO. ^{2 3 5 7 8}

Research Team

William O'Neill, MD

Principal Investigator

Henry Ford Hospital

Navin Kapur, MD

Principal Investigator

Tufts University Medical Center

Eligibility Criteria

This trial is for adults aged 18-85 who are experiencing their first heart attack and can get to the hospital within 1-6 hours of chest pain. They must be suitable for a procedure called Primary PCI and agree to participate by signing consent forms. People with severe heart valve issues, liver or kidney problems, certain lung conditions, or those in other studies can't join.

Inclusion Criteria

I arrived at the hospital within 1 to 6 hours after starting to feel chest pain.

Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent

I had a severe heart attack affecting the front part of my heart, confirmed by tests.

Exclusion Criteria

I might have an infection that is affecting my whole body.

I have not had a stroke, brain bleed, or lasting brain injury in the last 3 months.

I am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the IMPELLA® CP System for 30 minutes prior to catheterization procedure

Immediate

1 visit (in-person)

Post-procedure Monitoring

Infarct size evaluated using Cardiac Magnetic Resonance (CMR) imaging

3-5 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of cardiogenic shock and other clinical endpoints

12 months

Multiple visits (in-person)

Treatment Details

Interventions

• IMPELLA® CP System

Trial Overview The study tests if using the Impella CP device before reperfusion therapy (Primary PCI) can reduce heart damage during a heart attack compared to standard immediate treatment. Participants will have this device placed for 30 minutes prior to their catheterization procedure.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

Subjects randomized to the experimental arm will have their heart unloaded for 30 minutes on the Impella CP® device prior to PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Group II: Control Active Control 1 Intervention

Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.

Who Is Running the Clinical Trial?

Abiomed Inc.

Lead Sponsor

Trials

47

Recruited

33,900+

Founded

1981

Headquarters

Danvers, United States

Known For

Heart Recovery Technologies

Top Products

Impella heart pumps, AbioCor, Breethe OXY-1 System

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Outcomes of Impella CP insertion during cardiac arrest: A single center experience. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Budget Impact Analysis of Impella CP® Utilization in the Management of Cardiogenic Shock in France: A Health Economic Analysis. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Mechanical cardiac-assist devices in ST segment elevation myocardial infarction]. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

The use of Impella 2.5 in severe refractory cardiogenic shock complicating an acute myocardial infarction. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Retrospective analysis of circulatory support with the Impella CP® device in patients with therapy refractory cardiogenic shock. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients presenting with severe and profound cardiogenic shock: the Academic Medical Center intensive care unit experience. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Impella support for cardiogenic shock and high-risk percutaneous coronary intervention: A single-center experience. [2021]