Clinical trial NCT03000270: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
Official title: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI
Keywords: Infarct Size
Impella
Unloading
Left Ventricle
PPCI
STEMI
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: Infarct size at 30 Days
timeFrame: 30 Days
measure: MACCE at 30 Days
timeFrame: 30 Days
Secondary outcomes:
measure: Infarct Characteristics - LV mass
timeFrame: 3 - 5 and 30 Days
measure: Infarct Characteristics - area at risk
timeFrame: 3 - 5 and 30 Days
measure: 30 Day Safety Endpoint Rates
timeFrame: 30 Days
measure: Infarct Characteristics microvascular obstruction
timeFrame: 3-5 and 30 Days
measure: Left Ventricular Function- LV end systolic and diastolic volume index
timeFrame: 3-5 and 30 Days
measure: Left Ventricular Function - Ejection Fraction
timeFrame: 3-5 and 30 Days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Marietta
country: United States
facility: Wellstar/Kennestone Hospital
state: Georgia
city: Detroit
country: United States
facility: Detroit Medical Center
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Advocate Edward Hospital
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Danvers
country: United States
facility: ABIOMED, Inc.
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum
state: Michigan
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo Hospital
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
References:
citation: 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.