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

Not Applicable

Active, not recruiting

• Conditions: ST Elevation (STEMI) Myocardial Infarction of Anterior Wall

• Registration Number: NCT03947619
• Lead Sponsor: Abiomed Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Study Start: 2019-12-12
• Primary Completion: 2024-09-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-04
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 668

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

11. History or known hepatic insufficiency prior to catheterization

12. On renal replacement therapy

13. COPD with home oxygen therapy or on chronic steroid therapy

14. Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads

15. Prior CABG or LAD PCI

16. History of heart failure (documented history of EF <40% or documented hospitalization for HF within one (1) year prior to screening)

17. Prior aortic valve surgery or TAVR

18. Left bundle branch block (new or old)

19. History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit

20. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions

21. Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)

    Known contraindication to:

22. Undergoing MRI or use of gadolinium, [CrCl<30 ml/min, non-compatible implant, claustrophobia]

23. Heparin, pork, pork products or contrast media

24. Receiving a drug-eluting stent

25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint.

26. Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, severe cancer, hepatic or kidney disease), with life expectancy of ≤2 years or other abnormality that itself, or the treatment of which, could interfere with the conduct of the study or that, in the opinion of the Investigator and/or Sponsor's medical monitor, would pose an unacceptable risk to the patient in the study.

27. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures, including follow-up CMRs.

28. Subject belongs to a vulnerable population [Vulnerable patient populations are defined as Individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, prisoners, 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, and members of the armed forces.

    • A pregnancy test will be conducted prior to enrollment if required by Institutional Review Board (IRB), Regional Ethics Board (REB), local Ethics Committee (EC) or competent authority.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Infarct Size	3-5 days post-procedure	Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging

Secondary Outcome Measures

Name	Time	Method
Infarct Size, as a percent of Left Ventricular Mass	3-5 days	Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Impella CP® related Major Bleeding and Major Vascular complications	30 Days	Efficacy (Cardiogenic Shock)- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic. Secondary Safety (Major Bleeding and Vascular Complications); with pre-specified performance goals.
Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement	12 Months	Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.

Trial Locations

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, District of Columbia, United States

BayCare Cardiology - Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

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