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Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

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ClinicalTrials.gov Identifier: NCT01213251
Recruitment Status : Completed
First Posted : October 1, 2010
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Acute Myocardial Infarction
Pacing Therapy
Cardiac Remodeling
Heart Failure
Interventions: Device: Single Site Pacing
Device: Dual Site Pacing

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
3 patients exited study prior to randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Single Site Pacing Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site Pacing Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Control Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.

Participant Flow:   Overall Study
    Single Site Pacing   Dual Site Pacing   Control
STARTED   40   41   45 
COMPLETED   34 [1]   37 [1]   34 [1] 
NOT COMPLETED   6   4   11 
Death                2                1                2 
Exit                3                2                8 
Protocol Violation                1                1                0 
Missed 18-Month Follow-up                0                0                1 
[1] Patients that had the 18-Month follow-up visit



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Site Pacing Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Dual Site Pacing Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Control Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
Total Total of all reporting groups

Baseline Measures
   Single Site Pacing   Dual Site Pacing   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 40   41   45   126 
Age 
[Units: Years]
Mean (Standard Deviation) 		 59  (10)   60  (12)   54  (11)   58  (11) 
Gender 
[Units: Participants]
 		       
Female   12   9   12   33 
Male   28   32   33   93 
Race/Ethnicity, Customized 
[Units: Participants]
 		       
Asian   0   1   0   1 
Black or African American   3   3   5   11 
Hispanic or Latino   0   1   3   4 
White or Caucasian   19   16   18   53 
Not reportable per local laws or regulations   18   20   19   57 
BMI (kg/m^2) 
[Units: Kg/m^2]
Mean (Standard Deviation) 		 28  (6)   30  (5)   29  (4)   29  (5) 
Systolic Blood Pressure (mmHg) 
[Units: mmHg]
Mean (Standard Deviation) 		 114  (16)   118  (21)   119  (17)   117  (18) 
Diastolic Blood Pressure (mmHg) 
[Units: mmHg]
Mean (Standard Deviation) 		 73  (11)   71  (12)   74  (11)   73  (11) 
Heart Rate from Physical Exam (BPM) 
[Units: BPM]
Mean (Standard Deviation) 		 80  (15)   80  (13)   79  (14)   79  (14) 
Left Ventricular Ejection Fraction (LVEF) 
[Units: %]
Mean (Standard Deviation) 		 43  (9)   43  (10)   45  (9)   44  (9) 
Left Ventricular End Diastolic Volume (LVEDV) 
[Units: mL]
Mean (Standard Deviation) 		 107  (25)   107  (31)   116  (29)   111  (29) 
Left Ventricular End Systolic Volume (LVESV) 
[Units: mL]
Mean (Standard Deviation) 		 62  (23)   62  (22)   65  (24)   63  (23) 
QRS Width (msec) 
[Units: Msec]
Mean (Standard Deviation) 		 94  (17)   97  (17)   88  (13)   93  (16) 
NYHA [1] 
[Units: Participants]
 		       
I   9   12   11   32 
II   10   10   16   36 
III   15   12   9   36 
IV   0   0   0   0 
Subject does not have heart failure   6   7   8   21 
Missing   0   0   1   1 
[1] 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.
Minnesota Living with Heart Failure Questionnaire (MLWHF) [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 21  (25)   29  (26)   32  (29)   28  (27) 
[1] Minnesota Living with Heart Failure Questionnaire (MLWHF) is a health-related quality of life questionnaire. The scale ranges from 0 to 105. In particular, the lower the score the better is the patient’s quality of life.


  Outcome Measures

1.  Primary:   Change in Left Ventricular End Diastolic Volume (LVEDV)   [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  Show Outcome Measure 1

2.  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   [ Time Frame: 18 months post-implant ]
  Show Outcome Measure 2

3.  Secondary:   Frequency of Hospitalization for Cardiovascular Events   [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  Show Outcome Measure 3

4.  Secondary:   Change in New York Heart Association (NYHA) Functional Class   [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  Show Outcome Measure 4

5.  Secondary:   Change in 6-minute Walk Test Distance   [ Time Frame: 1 Month - 18 Month Follow Up Visit ]
  Show Outcome Measure 5

6.  Secondary:   Change in Quality of Life   [ Time Frame: Baseline - 18 Month Follow Up Visit ]
  Show Outcome Measure 6

7.  Secondary:   Incidence of Sudden Cardiac Death and Total Mortality   [ Time Frame: 18 Months post-randomization ]
  Show Outcome Measure 7

8.  Secondary:   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 ]
  Show Outcome Measure 8


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: PRomPT Clinical Team
Organization: Medtronic plc
phone: +1 800-328-2518
e-mail: MedtronicCRMtrials@medtronic.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01213251     History of Changes
Other Study ID Numbers: PRomPT
First Submitted: September 28, 2010
First Posted: October 1, 2010
Results First Submitted: August 8, 2016
Results First Posted: December 15, 2016
Last Update Posted: December 15, 2016