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Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study (DTU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03000270
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

Brief Summary:
Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible

Condition or disease Intervention/treatment Phase
STEMI Device: Impella unloading prior to PPCI Not Applicable

Detailed Description:

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI.

Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : August 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Prolonged unloading prior to PPCI
Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
Device: Impella unloading prior to PPCI
Impella unloading prior to PPCI

Active Comparator: Immediate unloading prior to PPCI
Activation of Impella CP immediately prior to primary percutaneous coronary intervention
Device: Impella unloading prior to PPCI
Impella unloading prior to PPCI




Primary Outcome Measures :
  1. Infarct size at 30 Days [ Time Frame: 30 Days ]
    Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI

  2. MACCE at 30 Days [ Time Frame: 30 Days ]

    A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days:

    • Cardiovascular mortality
    • Re-infarction
    • Stroke/TIA
    • Major vascular complication


Secondary Outcome Measures :
  1. Infarct Characteristics - LV mass [ Time Frame: 3 - 5 and 30 Days ]
    Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass

  2. Infarct Characteristics - area at risk [ Time Frame: 3 - 5 and 30 Days ]
    Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,

  3. 30 Day Safety Endpoint Rates [ Time Frame: 30 Days ]
    Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia

  4. Infarct Characteristics microvascular obstruction [ Time Frame: 3-5 and 30 Days ]
    Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)

  5. Left Ventricular Function- LV end systolic and diastolic volume index [ Time Frame: 3-5 and 30 Days ]
    Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi)

  6. Left Ventricular Function - Ejection Fraction [ Time Frame: 3-5 and 30 Days ]
    Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Age 21-80 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
  • Signed Informed Consent

Main Exclusion Criteria:

  • Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L
  • Inferior STEMI or suspected right ventricular failure
  • Suspected or known pregnancy
  • Suspected active infection
  • History or known hepatic insufficiency prior to catheterization
  • On dialysis therapy
  • Known contraindication to:
  • Undergoing MRI or use of gadolinium
  • 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

Information from the National Library of Medicine

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): NCT03000270


Locations
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United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, Georgia
Wellstar/Kennestone Hospital
Marietta, Georgia, United States, 30060
United States, Illinois
Detroit Medical Center
Detroit, Illinois, United States, 48201
Advocate Edward Hospital
Oakbrook Terrace, Illinois, United States, 60089
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
ABIOMED, Inc.
Danvers, Massachusetts, United States, 01923
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum
Grand Rapids, Michigan, United States, 49503
United States, New Jersey
Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Buffalo Hospital
Buffalo, New York, United States, 14203
Northwell Health
Manhasset, New York, United States, 11030
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 48201
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Abiomed Inc.

Additional Information:
Publications of Results:
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Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT03000270     History of Changes
Other Study ID Numbers: DTU - Safety and Feasibility
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Abiomed Inc.:
Infarct Size
Impella
Unloading
Left Ventricle
PPCI
STEMI
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases