Clinical trial NCT01213251: Post-Myocardial Infarction Remodeling Prevention Therapy
Official title: Post-Myocardial Infarction Remodeling Prevention Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Pacing Therapy
Cardiac Remodeling
Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: Baseline - 18 Month Follow Up Visit
Secondary outcomes:
measure: 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
timeFrame: 18 months post-implant
measure: Frequency of Hospitalization for Cardiovascular Events
timeFrame: Baseline - 18 Month Follow Up Visit
measure: Change in New York Heart Association (NYHA) Functional Class
timeFrame: Baseline - 18 Month Follow Up Visit
measure: Change in 6-minute Walk Test Distance
timeFrame: 1 Month - 18 Month Follow Up Visit
measure: Change in Quality of Life
timeFrame: Baseline - 18 Month Follow Up Visit
measure: Incidence of Sudden Cardiac Death and Total Mortality
timeFrame: 18 Months post-randomization
measure: Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
timeFrame: Baseline - 18 Month Follow Up Visit
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Lexington
country: United States
facility: Lexington Cardiac Research Foundation
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: Michigan Heart, PC
state: Michigan
city: Gastonia
country: United States
facility: Carolina Heart Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: The Chattanooga Heart Institute
state: Tennessee
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Research Institute, LLC
state: Tennessee
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Delgado Cardiovascular Associates
state: Texas
city: Spokane
country: United States
facility: Spokane Cardiology
state: Washington
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bordeaux-Pessac
country: France
facility: Hôpital Cardiologique du Haut-Lévêque
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Budapest
country: Hungary
facility: Maygar Honvédség Honvédkorház
city: Budapest
country: Hungary
facility: Semmelweis University Heart Center
city: King Fahad Medical City
country: Saudi Arabia
facility: Prince Salman Heart Centre
city: Kosice
country: Slovakia
facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Study officials:
affiliation: Columbia University
name: Gregg Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Angel Leon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.