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 : July 18, 2022
|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 :||October 2023|
|Estimated Study Completion Date :||October 2027|
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.
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|