NCT00099411

Brief Summary

The purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary intervention of the infarct related artery (IRA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

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

January 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2007

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

3.5 years

First QC Date

December 13, 2004

Last Update Submit

April 25, 2017

Conditions

Cardiovascular DiseasesCoronary DiseaseMyocardial InfarctionHeart DiseasesHeart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.

    The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.

    1 year

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who have experienced a heart attack 3 to 28 days prior to study entry.

You may qualify if:

  • Has experienced a heart attack 3 to 28 days prior to study entry
  • Has an occluded IRA at catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 10010, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseMyocardial InfarctionHeart DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • James E. Udelson

    Tufts Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2004

First Posted

December 14, 2004

Study Start

January 1, 2004

Primary Completion

June 30, 2007

Study Completion

June 30, 2007

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)