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

Primary Purpose

STEMI

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impella unloading prior to PPCI
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI focused on measuring Infarct Size, Impella, Unloading, Left Ventricle, PPCI, STEMI

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Good Samaritan Medical Center
  • Wellstar/Kennestone Hospital
  • Detroit Medical Center
  • Advocate Edward Hospital
  • Tufts Medical Center
  • ABIOMED, Inc.
  • Baystate Medical Center
  • Henry Ford Hospital
  • Spectrum
  • Hackensack Medical Center
  • University of Buffalo Hospital
  • Northwell Health
  • Albert Einstein Medical Center
  • Greenville Health System
  • West Virginia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Prolonged unloading prior to PPCI

Immediate unloading prior to PPCI

Arm Description

Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention

Activation of Impella CP immediately prior to primary percutaneous coronary intervention

Outcomes

Primary Outcome Measures

Infarct size at 30 Days
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
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

Secondary Outcome Measures

Infarct Characteristics - LV mass
Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass
Infarct Characteristics - area at risk
Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
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
Infarct Characteristics microvascular obstruction
Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)
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)
Left Ventricular Function - Ejection Fraction
Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)

Full Information

First Posted
December 12, 2016
Last Updated
May 2, 2019
Sponsor
Abiomed Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03000270
Brief Title
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
Acronym
DTU
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
June 19, 2018 (Actual)
Study Completion Date
August 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI
Keywords
Infarct Size, Impella, Unloading, Left Ventricle, PPCI, STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged unloading prior to PPCI
Arm Type
Active Comparator
Arm Description
Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
Arm Title
Immediate unloading prior to PPCI
Arm Type
Active Comparator
Arm Description
Activation of Impella CP immediately prior to primary percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
Impella unloading prior to PPCI
Intervention Description
Impella unloading prior to PPCI
Primary Outcome Measure Information:
Title
Infarct size at 30 Days
Description
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
Time Frame
30 Days
Title
MACCE at 30 Days
Description
A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days: Cardiovascular mortality Re-infarction Stroke/TIA Major vascular complication
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Infarct Characteristics - LV mass
Description
Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass
Time Frame
3 - 5 and 30 Days
Title
Infarct Characteristics - area at risk
Description
Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
Time Frame
3 - 5 and 30 Days
Title
30 Day Safety Endpoint Rates
Description
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
Time Frame
30 Days
Title
Infarct Characteristics microvascular obstruction
Description
Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)
Time Frame
3-5 and 30 Days
Title
Left Ventricular Function- LV end systolic and diastolic volume index
Description
Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi)
Time Frame
3-5 and 30 Days
Title
Left Ventricular Function - Ejection Fraction
Description
Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)
Time Frame
3-5 and 30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Wellstar/Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Detroit Medical Center
City
Detroit
State/Province
Illinois
ZIP/Postal Code
48201
Country
United States
Facility Name
Advocate Edward Hospital
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
ABIOMED, Inc.
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Spectrum
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of Buffalo Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
48201
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30586728
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.
Results Reference
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Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study

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