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 : Recruiting
First Posted : May 13, 2019
Last Update Posted : January 25, 2023
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||668 participants|
|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.|
|Official Title:||Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial|
|Actual Study Start Date :||December 12, 2019|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||October 2030|
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.
- Infarct Size [ Time Frame: 3-5 days post-procedure ]Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
- 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.
- 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.
- Cardiogenic Shock, CV mortality, Heart Failure, LVAD or Heart Transplant and ICD or CRT Placement [ Time Frame: 12 Months ]Efficacy- Composite clinical secondary endpoint. Compared between groups in a hierarchical order using the Finkelstein-Schoenfeld statistic.
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 18-85 years
- First myocardial infarction
- 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
- Patient presents to the hospital between 1 - 6 hours of ischemic pain onset
- Patient indicated for Primary PCI
- Patient or the patient's Legally Authorized Representative (where applicable) has signed Informed Consent
- Patient transferred from an outside hospital where invasive coronary procedure was attempted (including diagnostic catheterization)
- 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
- Administration of fibrinolytic therapy within 24 hours prior to enrollment
- 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
- Inferior STEMI or suspected right ventricular failure
- Any contraindication or inability to place the Impella, including peripheral vascular disease, tortuous vascular anatomy, femoral bruits or absent pedal pulses
- Severe aortic stenosis
- Acute cardiac mechanical complication: LV free wall rupture OR Interventricular septum rupture OR Acute mitral regurgitation
- Suspected or known pregnancy
- Suspected systemic active infection
- History or known hepatic insufficiency prior to catheterization
- On renal replacement therapy
- COPD with home oxygen therapy or on chronic steroid therapy
- Known or evidence of prior myocardial infarction, including pathologic Q waves in non-anterior leads
- Prior CABG or LAD PCI
- History of heart failure (EF <40% or documented hospitalization for HF within one (1) year prior to screening)
- Prior aortic valve surgery or TAVR
- Left bundle branch block (new or old)
- History of stroke/TIA within the prior 3 months, any history of Intracranial Hemorrhage or any permanent neurological deficit
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), any recent GU or GI bleed, or will refuse blood transfusions
Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)
Known contraindication to:
- Undergoing MRI or use of gadolinium, [CrCl<30 ml/min, non-compatible implant, claustrophobia]
- Heparin, pork, pork products or contrast media
- Receiving a drug-eluting stent
- 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.
- 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.
- 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.
- 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].
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
|Contact: Poornima Sood, MD, MBAfirstname.lastname@example.org|
|Contact: Deborah Wood, RNemail@example.com|
|Principal Investigator:||Navin Kapur, MD||Tufts University Medical Center|
|Principal Investigator:||William O'Neill, MD||Henry Ford Hospital|
|Responsible Party:||Abiomed Inc.|
|Other Study ID Numbers:||
The STEMI-DTU Trial
|First Posted:||May 13, 2019 Key Record Dates|
|Last Update Posted:||January 25, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
ST Elevation Myocardial Infarction