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

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ClinicalTrials.gov Identifier: NCT03947619
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date May 13, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
Infarct Size [ Time Frame: 3-5 days post-procedure ]
Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Infarct Size, as a percent of Left Ventricular Mass [ Time Frame: 3-5 days ]
    Efficacy- Composite clinical secondary endpoint, Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
  • Cardiogenic Shock at ≥ 24h from enrollment and Impella CP® related Major Bleeding and Major Vascular complications [ Time Frame: 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.
  • CV mortality, Heart Failure Hospitalization and ICD or CRT Placement [ Time Frame: 24 Months ]
    Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Official Title  ICMJE Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
A prospective, multicenter, randomized, controlled open-label two-arm trial with an adaptive design
Masking: Single (Outcomes Assessor)
Masking Description:
Blinding of the operator and patient is not possible given the nature of the treatment.
Primary Purpose: Treatment
Condition  ICMJE ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Intervention  ICMJE Device: Impella CP® placement prior to reperfusion with Primary PCI
Subjects randomized to the experimental arm, will undergo Impella CP® placement through a femoral arterial sheath and the Impella device will be activated to unload the left ventricle.
Study Arms  ICMJE
  • Experimental: Experimental

    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.

    Intervention: Device: Impella CP® placement prior to reperfusion with Primary PCI
  • No Intervention: Control
    Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
688
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2027
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-80 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
  4. Patient presents to the hospital between 1 - 5 hours of chest pain onset
  5. Patient indicated for Primary PCI
  6. Patient or the patient's Legally Authorized Representative 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 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
  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, e.g. 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 end point.
  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, 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, members of the armed forces, and persons kept in detention].
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shon Chakrabarti, MD, MPH 978-646-1511 schakrabarti@abiomed.com
Contact: Carrie Cameron 978.882.8434 ccameron@abiomed.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947619
Other Study ID Numbers  ICMJE 06250
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abiomed Inc.
Study Sponsor  ICMJE Abiomed Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Navin Kapur, MD Tufts University Medical Center
Principal Investigator: William O'Neill, MD Henry Ford Hospital
PRS Account Abiomed Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP