Clinical trial NCT00605631: The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Official title: The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Myocardial Infarction
Keywords: Pacing
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the effect of pacing on post-MI patients.


Eligibility criteria: Inclusion Criteria:

* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
* Patient has had a clinically documented anterior myocardial infarction which occurred within the last 14 days
* Measured peak CK \> 2000 mU/mL within 72 hours of MI.
* QRS duration \< 120 ms measured by 12-lead ECG at any time after most recent MI

Exclusion Criteria:

* Patient has atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) at time of enrollment
* Patient is in cardiogenic shock defined by systolic blood pressure \< 90 mmHg and on pressor/inotrope medications at time of potential enrollment
* Patient has 2 or 3 degree heart block at time of potential enrollment
* Patient has undergone or is scheduled for a coronary artery bypass graft procedure, 30 days before or 30 days after date of potential enrollment
* Patient has a known life expectancy of less than 6 months due to non cardiac causes
* Patient has marked renal dysfunction defined as Creatinine \> 2.5 mg/dL at time of enrollment
* Patient enrolled in any concurrent study that may confound the results of the study
* Patient is in class IV heart failure
* Patient is on the heart transplant list
* Patient already has an implanted pacemaker, ICD, or CRT device
* Patient is pregnant or plans to be pregnant during the course of the study
* Both

Primary outcomes:
measure: LVEDV
timeFrame: 12 months
Secondary outcomes:
measure: LVESV
timeFrame: 12 months
measure: ECG
timeFrame: 12 months
measure: Blood chemistry
timeFrame: 12 months
measure: Device parameters
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
measure: Cardiac echo
timeFrame: 12 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
Study officials:
affiliation: Christ Hospital Cincinnati
name: Eugene Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung ES, Dan D, Solomon SD, Bank AJ, Pastore J, Iyer A, Berger RD, Franklin JO, Jones G, Machado C, Stolen CM. Effect of peri-infarct pacing early after myocardial infarction: results of the prevention of myocardial enlargement and dilatation post myocardial infarction study. Circ Heart Fail. 2010 Nov;3(6):650-8. doi: 10.1161/CIRCHEARTFAILURE.110.945881. Epub 2010 Sep 17.