Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Actual Study Start Date : | December 12, 2019 |
Estimated Primary Completion Date : | October 2023 |
Estimated Study Completion Date : | October 2027 |
Arm | Intervention/treatment |
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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.
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No Intervention: Control
Primary PCI. Each site is required to have one "roll-in" per arm to test the study protocol before beginning enrollment.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patient on systemic anticoagulation pre-procedure (including factor Xa inhibitors, thrombin inhibitors, warfarin)
Known contraindication to:
Contact: Shon Chakrabarti, MD, MPH | 978-646-1511 | schakrabarti@abiomed.com | |
Contact: Carrie Cameron | 978.882.8434 | ccameron@abiomed.com |
Principal Investigator: | Navin Kapur, MD | Tufts University Medical Center | |
Principal Investigator: | William O'Neill, MD | Henry Ford Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 6, 2019 | ||||||||
First Posted Date ICMJE | May 13, 2019 | ||||||||
Last Update Posted Date | May 11, 2021 | ||||||||
Actual Study Start Date ICMJE | December 12, 2019 | ||||||||
Estimated Primary Completion Date | October 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Infarct Size [ Time Frame: 3-5 days post-procedure ] Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR) imaging
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Original Primary Outcome Measures ICMJE |
Infarct Size [ Time Frame: 3-5 days post-procedure ] Infarct size normalized to the left ventricular mass, evaluated using Cardiac Magnetic Resonance (CMR)
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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
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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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
668 | ||||||||
Original Estimated Enrollment ICMJE |
688 | ||||||||
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany, Italy, Switzerland, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03947619 | ||||||||
Other Study ID Numbers ICMJE | The STEMI-DTU Trial | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Abiomed Inc. | ||||||||
Study Sponsor ICMJE | Abiomed Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Abiomed Inc. | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |