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

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

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

Study Overview

• Status: Completed
• Conditions: STEMI
• Intervention / Treatment: Device: Impella unloading prior to PPCI

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Infarct Characteristics microvascular obstruction	Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)	3-5 and 30 Days
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
Left Ventricular Function - Ejection Fraction	Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)	3-5 and 30 Days

Collaborators and Investigators

• Sponsor: Abiomed Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ACTUAL): June 19, 2018
• Study Completion (ACTUAL): August 16, 2018

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (ESTIMATE): December 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: STEMI; PPCI; Impella; Infarct Size; Left Ventricle; Unloading
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: DTU - Safety and Feasibility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes