The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Post Myocardial Infarction Clinical Trial

Official title:

The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605631
• Other study ID #: MENDMI
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: April 4, 2017
• Start date: May 2005
• Est. completion date: March 2009

Study information

• Verified date: April 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertrophy
• Infarction
• Myocardial Infarction
• Post Myocardial Infarction

Intervention

Device:
• Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.

Locations

Country	Name	City	State
United States	Christ Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 myocar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LVEDV		12 months
Secondary	LVESV		12 months
Secondary	ECG		12 months
Secondary	Blood chemistry		12 months
Secondary	Device parameters		12 months
Secondary	Quality of Life		12 months
Secondary	Cardiac echo		12 months