Post-Myocardial Infarction Remodeling Prevention Therapy

NCT01213251 | Completed Phase 2 Results DMC

• 1 other identifier: PRomPT
• Study Type: interventional
• Target: 129
• Locations: 7 countries
• Sites: 26

Brief Summary

The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.

Conditions

Acute Myocardial Infarction; Pacing Therapy; Cardiac Remodeling; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular End Diastolic Volume (LVEDV)

  Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.

  Baseline - 18 Month Follow Up Visit

Secondary Outcomes (7)

• Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events

  18 months post-implant

• Frequency of Hospitalization for Cardiovascular Events

  Baseline - 18 Month Follow Up Visit

• Change in New York Heart Association (NYHA) Functional Class

  Baseline - 18 Month Follow Up Visit

• Change in 6-minute Walk Test Distance

  1 Month - 18 Month Follow Up Visit

• Change in Quality of Life

  Baseline - 18 Month Follow Up Visit

Study Arms (3)

Single Site Pacing

EXPERIMENTAL

Device: Single Site Pacing

Dual Site Pacing

EXPERIMENTAL

Device: Dual Site Pacing

Control

NO INTERVENTION

Interventions

Single Site Pacing DEVICE

Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.

Single Site Pacing

Dual Site Pacing DEVICE

Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.

Dual Site Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Myocardial Infarction (MI) within the past 10 days
• Peak Creatine Phosphokinase (CPK) greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT) greater than 10 micrograms/Litre (mcg/L)
• At least 18 years old
• Willing to comply with the protocol

You may not qualify if:

• Documented MI greater than 10 days
• Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less than 30 milliliters/minute/1.73 square meter
• Life expectancy less than 18 months, as determined by a physician
• Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) device
• QRS duration greater than 120 milliseconds (ms)
• Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure planned
• Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia
• Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is terminated electrically or pharmacologically
• Permanent AF that is non self terminating, with cardioversion failed or not attempted within the past year
• New York Heart Association (NYHA) Class IV
• Non-ischemic cardiomyopathy
• Pregnant or planning to become pregnant during the study
• Enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from Medtronic, documenting that there is not a concern that co-enrollment could confound the results of this trial.
• Breast feeding
• Of a vulnerable population as determined by local law or requirement, or a physician

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (26)

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Lexington Cardiac Research Foundation

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Michigan Heart, PC

Ypsilanti, Michigan, 48197, United States

Location

Carolina Heart Specialists

Gastonia, North Carolina, 28054, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The Chattanooga Heart Institute

Chattanooga, Tennessee, 37404, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Saint Thomas Research Institute, LLC

Nashville, Tennessee, 37205, United States

Location

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Delgado Cardiovascular Associates

Houston, Texas, 77004, United States

Location

Spokane Cardiology

Spokane, Washington, 99204, United States

Location

Rigshospitalet

Copenhagen, Denmark

Location

Hôpital Cardiologique du Haut-Lévêque

Bordeaux-Pessac, France

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

University Hospital Mannheim

Mannheim, Germany

Location

Maygar Honvédség Honvédkorház

Budapest, Hungary

Location

Semmelweis University Heart Center

Budapest, Hungary

Location

Prince Salman Heart Centre

King Fahad Medical City, Saudi Arabia

Location

Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

Košice, Slovakia

Location

Related Publications (1)

• Stone GW, Chung ES, Stancak B, Svendsen JH, Fischer TM, Kueffer F, Ryan T, Bax J, Leon A; PRomPT Trial Investigators. Peri-infarct zone pacing to prevent adverse left ventricular remodelling in patients with large myocardial infarction. Eur Heart J. 2016 Feb 1;37(5):484-93. doi: 10.1093/eurheartj/ehv436. Epub 2015 Aug 30.

  PMID: 26321236 DERIVED

Related Links

• The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and Rationale

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: PRomPT Clinical Team
• Organization: Medtronic plc

MedtronicCRMtrials@medtronic.com

+1 800-328-2518

Study Officials

• Gregg Stone, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Angel Leon, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 1, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 15, 2016
• Results First Posted: December 15, 2016

Record last verified: 2016-10

Locations

FR (2); SA (1); SL (1); DE (2); DK (1); US (17); HU (2)