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
|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 :||688 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|
|Estimated Study Start Date :||October 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947619
|Contact: Shon Chakrabarti, MD, MPHfirstname.lastname@example.org|
|Contact: Carrie Cameronemail@example.com|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Grand Rapids, Michigan, United States, 49503|
|Principal Investigator:||Navin Kapur, MD||Tufts University Medical Center|
|Principal Investigator:||William O'Neill, MD||Henry Ford Hospital|