NCT00605631

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

3.8 years

First QC Date

December 20, 2007

Last Update Submit

April 4, 2017

Conditions

Post Myocardial Infarction

Keywords

Pacing

Outcome Measures

Primary Outcomes (1)

  • LVEDV

    12 months

Secondary Outcomes (6)

  • LVESV

    12 months

  • ECG

    12 months

  • Blood chemistry

    12 months

  • Device parameters

    12 months

  • Quality of Life

    12 months

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

2

ACTIVE COMPARATOR
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

3

OTHER
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System

Interventions

Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead SystemDEVICE

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.

123

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Related 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 myocardial infarction study. Circ Heart Fail. 2010 Nov;3(6):650-8. doi: 10.1161/CIRCHEARTFAILURE.110.945881. Epub 2010 Sep 17.

    PMID: 20852059RESULT

Study Officials

  • Eugene Chung, MD

    Christ Hospital Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 31, 2008

Study Start

May 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)