Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

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
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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

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.
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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.

1.  Primary:

Change in Left Ventricular End Diastolic Volume (LVEDV)   [ Time Frame: Baseline - 18 Month Follow Up Visit ]

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 ]

3.  Secondary:

Frequency of Hospitalization for Cardiovascular Events   [ Time Frame: Baseline - 18 Month Follow Up Visit ]

4.  Secondary:

Change in New York Heart Association (NYHA) Functional Class   [ Time Frame: Baseline - 18 Month Follow Up Visit ]

5.  Secondary:

Change in 6-minute Walk Test Distance   [ Time Frame: 1 Month - 18 Month Follow Up Visit ]

6.  Secondary:

Change in Quality of Life   [ Time Frame: Baseline - 18 Month Follow Up Visit ]

7.  Secondary:

Incidence of Sudden Cardiac Death and Total Mortality   [ Time Frame: 18 Months post-randomization ]

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 ]

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
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