Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

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.

Condition or disease Intervention/treatment Phase
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall Device: Impella CP® placement prior to reperfusion with Primary PCI Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 688 participants
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
Official Title: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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.

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.

No Intervention: Control
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.



Primary Outcome Measures :
  1. Infarct Size [ Time Frame: 3-5 days post-procedure ]
    Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947619


Contacts
Layout table for location contacts
Contact: Shon Chakrabarti, MD, MPH 978-646-1511 schakrabarti@abiomed.com
Contact: Carrie Cameron 978.882.8434 ccameron@abiomed.com

Locations
Layout table for location information
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Abiomed Inc.
Investigators
Layout table for investigator information
Principal Investigator: Navin Kapur, MD Tufts University Medical Center
Principal Investigator: William O'Neill, MD Henry Ford Hospital

Layout table for additonal information
Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT03947619     History of Changes
Other Study ID Numbers: 06250
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

Layout table for additional information
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

Keywords provided by Abiomed Inc.:
Anterior STEMI
ST-Elevated MI
Cardiac Unloading

Additional relevant MeSH terms:
Layout table for MeSH terms
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases