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Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial | Clinical Trials | Clareo Health

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Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

NCT03947619•Abiomed Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-85 years
•2. First myocardial infarction
•3. Acute anterior STEMI with ≥2 mm in 2 or more contiguous anterior leads or ≥ 4 mm total ST segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
•4. Patient presents to the enrolling hospital where the index procedure will be performed between 1 - 6 hours after onset of continuous ischemic pain
•5. Patient indicated for Primary PCI
•6. Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent

Exclusion Criteria

•1. Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
•2. Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition, or any global or focal neurological deficit
•3. Administration of fibrinolytic therapy within 24 hours prior to enrollment
•4. Cardiogenic shock defined as: systemic hypotension (systolic BP \<90 mmHg or the need for inotropes/pressors to maintain a systolic BP \>90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the catheterization laboratory, clinical evidence of end organ hypoperfusion or use of IABP or any other circulatory support device
•5. Inferior STEMI or suspected right ventricular failure
•6. Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
•7. Severe aortic stenosis
•8. Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
•9. Suspected or known pregnancy
•10. Suspected systemic active infection
+20 more criteria

Locations (63)

University of Alabama at Birmingham

Birmingham, Alabama, United States

HonorHealth Research Institute

Scottsdale, Arizona, United States

The University of Arizona

Tucson, Arizona, United States

Emanate Health Intercommunity Hospital / Valley Clinical Trials, Inc.

Covina, California, United States

Riverside Community Hospital

Riverside, California, United States

St. Anthony Hospital

Lakewood, Colorado, United States

Hartford Health Care

Hartford, Connecticut, United States

Christiana Care Health Services

Newark, Delaware, United States

George Washington University

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

BayCare Cardiology - Morton Plant Hospital

Clearwater, Florida, United States

Key Dates

Start Date

December 12, 2019

Primary Completion Date

September 4, 2024

Completion Date

October 1, 2030

Last Updated

March 6, 2026

Enrollment

527

ACTUAL participants

Conditions

ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

Interventions

Impella CP® placement prior to reperfusion with Primary PCI

DEVICE