Acute Myocardial InfarctionPhase 2PRomPTNCT01213251
Post-Myocardial Infarction Remodeling Prevention Therapy
A Phase 2 study testing Single Site Pacing and Dual Site Pacing in people with Acute Myocardial Infarction and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Pacing Therapy, Cardiac Remodeling
- What is being tested?
- Single Site Pacing and Dual Site Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Dec 2010to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
United States17 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Chattanooga Heart Institute
Chattanooga, Tennessee, 37404
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226
Carolina Heart Specialists
Gastonia, North Carolina, 28054
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Delgado Cardiovascular Associates
Houston, Texas, 77004
Lexington Cardiac Research Foundation
Lexington, Kentucky, 40503
Kaiser Permanente
Los Angeles, California, 90027
Saint Thomas Research Institute, LLC
Nashville, Tennessee, 37205
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
Spokane Cardiology
Spokane, Washington, 99204
Michigan Heart, PC
Ypsilanti, Michigan, 48197
France2 sites
Hôpital Cardiologique du Haut-Lévêque
Bordeaux-Pessac
Centre Hospitalier Régional Universitaire de Lille
Lille
Germany2 sites
Herzzentrum Leipzig GmbH
Leipzig
University Hospital Mannheim
Mannheim
Hungary2 sites
Maygar Honvédség Honvédkorház
Budapest
Semmelweis University Heart Center
Budapest
Slovakia1 site
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
Košice
About this study
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.
- Being tested
- Single Site Pacing, Dual Site Pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Site PacingDevice
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site PacingDevice
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
| Study group | Role | What they receive |
|---|---|---|
| Single Site Pacing | Experimental | Not described Receives: Device: Single Site Pacing |
| Dual Site Pacing | Experimental | Not described Receives: Device: Dual Site Pacing |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 18 months post-implant
Frequency of Hospitalization for Cardiovascular Events
Number of hospitalizations related to cardiovascular events.
Measured: Baseline - 18 Month Follow Up Visit
Change in New York Heart Association (NYHA) Functional Class
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.
Measured: Baseline - 18 Month Follow Up Visit
Change in 6-minute Walk Test Distance
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.
Measured: 1 Month - 18 Month Follow Up Visit
Change in Quality of Life
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.
Measured: Baseline - 18 Month Follow Up Visit
Incidence of Sudden Cardiac Death and Total Mortality
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.
Measured: 18 Months post-randomization
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.
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.
Measured: Baseline - 18 Month Follow Up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg Stone, MD, Principal investigator, Columbia UniversityAngel Leon, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213251
- Sponsor's protocol ID
- PRomPT
- Acronym
- PRomPT
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2010
- Last updated
- 15 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26321236
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Myocardial Infarction Remodeling Prevention Therapy
- ClinicalTrials.gov ID
- NCT01213251
- Acronym / sponsor ID
- PRomPT / PRomPT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Posted 15 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Site Pacing | Experimental | Device: Single Site Pacing |
| Dual Site Pacing | Experimental | Device: Dual Site Pacing |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Site PacingSubjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead. | Device | Single Site Pacing |
| Dual Site PacingSubjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead. | Device | Dual Site Pacing |
Primary outcome
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.
7 secondary outcomes
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
Frequency of Hospitalization for Cardiovascular Events
Time frame: Baseline - 18 Month Follow Up Visit
Change in New York Heart Association (NYHA) Functional Class
Time frame: Baseline - 18 Month Follow Up Visit
Change in 6-minute Walk Test Distance
Time frame: 1 Month - 18 Month Follow Up Visit
Change in Quality of Life
Time frame: Baseline - 18 Month Follow Up Visit
Incidence of Sudden Cardiac Death and Total Mortality
Time frame: 18 Months post-randomization
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26321236Stone 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.
- The Post-Myocardial Infarction Pacing Remodeling Prevention Therapy (PRomPT) Trial: Design and RationaleLink provided by the sponsor.
Related trials for Acute Myocardial Infarction
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg Stone, MD principal investigator
Columbia University
Angel Leon, MD principal investigator
Emory University
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single Site Pacing and Dual Site Pacing in people with Acute Myocardial Infarction and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, France, Germany, Hungary, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular End Diastolic Volume (LVEDV) (time frame: Baseline - 18 Month Follow Up Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.