| 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 |
| 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 |
|---|---|
|
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.
|
| 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 |
Show 49 study locations
| Principal Investigator: | Navin Kapur, MD | Tufts University Medical Center | |
| Principal Investigator: | William O'Neill, MD | Henry Ford Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||
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* 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 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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