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Can better Decision-Making save heart attack victims in shock?

NCT ID NCT05800951

Knowledge-focused Sponsor: Henry Ford Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how doctors treat people having a severe heart attack complicated by cardiogenic shock, where the heart can't pump enough blood. Researchers will track 124 patients at 20 U.S. hospitals to see how decisions about using mechanical heart support devices affect survival. The goal is to learn which escalation strategies work best, not to test a new drug or device.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mechanical circulatory support devices
What this could lead to
If successful, this study could help doctors make better decisions about when and how to escalate support for heart attack patients in shock, potentially improving survival rates.
What could go wrong
This is an observational study, not a treatment test, so it won't directly prove a new therapy works. Results may vary across hospitals and might not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

124 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who present with an acute myocardial infarction (AMI) with cardiogenic shock (AMICS) prior to PCI.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI). 2. Cardiogenic Shock present as defined by the presence of 2 OR MORE of the following criteria prior to PCI: * Hypotension: systolic blood pressure ≤ 90mmHg at baseline (prior to PCI) or the use of inotropes or vasopressors to maintain SBP ≥ 90mmHg * Evidence of end organ hypoperfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria * Hemodynamic criteria: Cardiac Index of \< 2.2 L/min/m2 or a cardiac power output (CPO) of ≤ 0.6 watts 3. Patient underwent PCI within 12 hours of hospital presentation. Exclusion Registry Exclusion Criteria: AMICS patients who meet any of the following study exclusion criteria will have a limited set of data collected via a single-page Patient Exclusion Form completed and submitted within 45 days of hospital discharge, which includes the reason for exclusion, date of index PCI, and assessment of patient survival to hospital discharge: 1. Evidence of Anoxic Brain Injury 2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes 3. IABP placed prior to MCS 4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock 5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.) 6. Active bleeding for which MCS is contraindicated 7. Recent major surgery for which MCS is contraindicated 8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture) 9. Known left ventricular thrombus for which MCS is contraindicated 10. Mechanical aortic prosthetic valve 11. Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction acute subendocardial myocardial infarction cardiogenic shock myocardial infarction Non-ST Elevated Myocardial Infarction Shock, Cardiogenic ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myocardial infarction Acute myocardial infarction of left ventricle Acute myocardial infarction of right ventricle (disorder) Acute myocardial infarction with ST elevation Cardiogenic shock NSTEMI Nstemi - non-ST segment elevation mi STEMI Stemi - ST elevation myocardial infarction

Contacts and locations

Locations

  • Ascenion St. John Hospital

    Detroit, Michigan, 48236, United States

  • Fort Sanders Regional Medical Center

    Knoxville, Tennessee, 37916, United States

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037, United States

  • Hackensack Meridian Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103, United States

  • Loma Linda University Medical Center

    Loma Linda, California, 92354, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Northside Hospital Atlanta

    Atlanta, Georgia, 30342, United States

  • Parkwest Medical Center

    Nashville, Tennessee, 37923, United States

  • Providence St. Joseph Hospital Orange

    Orange, California, 92868, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Spectrum Health Hospitals Fred and Lena Meijer Heart Center

    Grand Rapids, Michigan, 49503, United States

  • St. Anthony Hospital

    Lakewood, Colorado, 80228, United States

  • St. Elizabeth Edgewood Hospital

    Edgewood, Kentucky, 41017, United States

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • UVA University Hospital

    Charlottesville, Virginia, 22903, United States

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