Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
DTU
1 other identifier
interventional
50
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
December 22, 2016
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2018
CompletedMay 6, 2019
November 1, 2018
1.2 years
December 12, 2016
May 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Infarct size at 30 Days
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
30 Days
MACCE at 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
30 Days
Secondary Outcomes (6)
Infarct Characteristics - LV mass
3 - 5 and 30 Days
Infarct Characteristics - area at risk
3 - 5 and 30 Days
30 Day Safety Endpoint Rates
30 Days
Infarct Characteristics microvascular obstruction
3-5 and 30 Days
Left Ventricular Function- LV end systolic and diastolic volume index
3-5 and 30 Days
- +1 more secondary outcomes
Study Arms (2)
Prolonged unloading prior to PPCI
ACTIVE COMPARATORActivation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
Immediate unloading prior to PPCI
ACTIVE COMPARATORActivation of Impella CP immediately prior to primary percutaneous coronary intervention
Interventions
Impella unloading prior to PPCI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abiomed Inc.lead
Study Sites (15)
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Wellstar/Kennestone Hospital
Marietta, Georgia, 30060, United States
Detroit Medical Center
Detroit, Illinois, 48201, United States
Advocate Edward Hospital
Oakbrook Terrace, Illinois, 60089, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
ABIOMED, Inc.
Danvers, Massachusetts, 01923, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Spectrum
Grand Rapids, Michigan, 49503, United States
Hackensack Medical Center
Hackensack, New Jersey, 07601, United States
University of Buffalo Hospital
Buffalo, New York, 14203, United States
Northwell Health
Manhasset, New York, 11030, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Greenville Health System
Greenville, South Carolina, 48201, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Related Publications (1)
Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C, Wohns DHW, O'Neill WW. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.
PMID: 30586728RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2016
First Posted
December 22, 2016
Study Start
April 11, 2017
Primary Completion
June 19, 2018
Study Completion
August 16, 2018
Last Updated
May 6, 2019
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share