Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)
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| ClinicalTrials.gov Identifier: NCT01213251 |
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Recruitment Status :
Completed
First Posted : October 1, 2010
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myocardial Infarction Pacing Therapy Cardiac Remodeling Heart Failure | Device: Single Site Pacing Device: Dual Site Pacing | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 129 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Post-Myocardial Infarction Remodeling Prevention Therapy |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | April 2016 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Single Site Pacing |
Device: Single Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. |
| Experimental: Dual Site Pacing |
Device: Dual Site Pacing
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. |
| No Intervention: Control |
- Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: Baseline - 18 Month Follow Up Visit ]
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.
- 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 [ Time Frame: 18 months post-implant ]Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.
- Frequency of Hospitalization for Cardiovascular Events [ Time Frame: Baseline - 18 Month Follow Up Visit ]Number of hospitalizations related to cardiovascular events.
- Change in New York Heart Association (NYHA) Functional Class [ Time Frame: Baseline - 18 Month Follow Up Visit ]
The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.
NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change".
Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.
- Change in 6-minute Walk Test Distance [ Time Frame: 1 Month - 18 Month Follow Up Visit ]
Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.
Change is defined as month 18 minus baseline.
Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.
- Change in Quality of Life [ Time Frame: Baseline - 18 Month Follow Up Visit ]
Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.
Change is defined as month 18 minus baseline.
Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.
- Incidence of Sudden Cardiac Death and Total Mortality [ Time Frame: 18 Months post-randomization ]
Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.
Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.
- 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. [ Time Frame: Baseline - 18 Month Follow Up Visit ]
Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.
Variables resulting in statistical significant (p<0.05) are reported.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213251
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| Principal Investigator: | Gregg Stone, MD | Columbia University | |
| Principal Investigator: | Angel Leon, MD | Emory University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
| ClinicalTrials.gov Identifier: | NCT01213251 |
| Other Study ID Numbers: |
PRomPT |
| First Posted: | October 1, 2010 Key Record Dates |
| Results First Posted: | December 15, 2016 |
| Last Update Posted: | December 15, 2016 |
| Last Verified: | October 2016 |
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Myocardial Infarction Infarction Heart Diseases Cardiovascular Diseases Ischemia |
Pathologic Processes Necrosis Myocardial Ischemia Vascular Diseases |