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

STEMI Clinical Trial

— DTU  

Official title:

Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000270
• Other study ID #: DTU - Safety and Feasibility
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: August 16, 2018

Study information

• Verified date: November 2018
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 16, 2018
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• STEMI

Intervention

Device:
• Impella unloading prior to PPCI
Impella unloading prior to PPCI

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Buffalo Hospital	Buffalo	New York
United States	ABIOMED, Inc.	Danvers	Massachusetts
United States	Detroit Medical Center	Detroit	Illinois
United States	Henry Ford Hospital	Detroit	Michigan
United States	Spectrum	Grand Rapids	Michigan
United States	Greenville Health System	Greenville	South Carolina
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	Northwell Health	Manhasset	New York
United States	Wellstar/Kennestone Hospital	Marietta	Georgia
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Advocate Edward Hospital	Oakbrook Terrace	Illinois
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Infarct Characteristics - LV mass	Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass	3 - 5 and 30 Days
Secondary	Infarct Characteristics - area at risk	Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,	3 - 5 and 30 Days
Secondary	30 Day Safety Endpoint Rates	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	30 Days
Secondary	Infarct Characteristics microvascular obstruction	Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)	3-5 and 30 Days
Secondary	Left Ventricular Function- LV end systolic and diastolic volume index	Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi)	3-5 and 30 Days
Secondary	Left Ventricular Function - Ejection Fraction	Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)	3-5 and 30 Days

External Links

•   Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.