Post-Myocardial Infarction Remodeling Prevention Therapy

Heart Failure Clinical Trial

— PRomPT  

Official title:

Post-Myocardial Infarction Remodeling Prevention Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01213251
• Other study ID #: PRomPT
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 28, 2010
• Last updated: April 23, 2014
• Start date: December 2010

Study information

• Verified date: February 2014
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencySlovakia: State Institute for Drug ControlSaudi Arabia: No oversight authority approval requiredFrance:French Agency for the Safety of Health ProductsHungary:Office of Health Authorization and Administrative ProceduresGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• MI within the past 10 days

• Peak 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Device:
• Single Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
• Dual Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
France	Hôpital Cardiologique du Haut-Lévêque	Bordeaux-Pessac
France	Centre Hospitalier Régional Universitaire de Lille	Lille
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	University Hospital Mannheim	Mannheim
Hungary	Maygar Honvédség Honvédkorház	Budapest
Hungary	Semmelweis University Heart Center	Budapest
Saudi Arabia	Prince Salman Heart Centre	King Fahad Medical City
Slovakia	Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.	Kosice
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	The Chattanooga Heart Institute	Chattanooga	Tennessee
United States	Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Carolina Heart Specialists	Gastonia	North Carolina
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Delgado Cardiovascular Associates	Houston	Texas
United States	Lexington Cardiac Research Foundation	Lexington	Kentucky
United States	Kaiser Permanente	Los Angeles	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Arizona Arrhythmia Consultants	Scottsdale	Arizona
United States	Spokane Cardiology	Spokane	Washington
United States	Michigan Heart, PC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Denmark,  France,  Germany,  Hungary,  Saudi Arabia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular end diastolic volume (LVEDV)		Baseline - 18 Month Follow Up Visit	No
Secondary	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		Baseline - 18 Month Follow Up Visit	No
Secondary	Frequency of hospitalization for heart failure and cardiovascular events		Baseline - 18 Month Follow Up Visit	No
Secondary	Change in New York Heart Association (NYHA) functional class		Baseline - 18 Month Follow Up Visit	No
Secondary	Change in 6-minute walk test distance		Baseline - 18 Month Follow Up Visit	No
Secondary	Change in quality of life		Baseline - 18 Month Follow Up Visit	No
Secondary	Incidence of sudden cardiac death and total mortality		Baseline - 18 Month Follow Up Visit	No
Secondary	Association between clinical characteristics; including peak creatinine phosphokinase (CPK), peak troponin, lead location, time from MI onset to implant, and change in LV volumes.		Baseline - 18 Month Follow Up Visit	No