NCT00661232

Brief Summary

The purpose of this study is to test the hypothesis of whether contrast enhanced Magnetic Resonance Imaging can be used to predict improvement of the wall motion in regions of the heart with abnormal movement following bypass surgery or percutaneous angioplasty in various institutions across three continents.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Geographic Reach
6 countries

7 active sites

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

August 11, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2011

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

7.4 years

First QC Date

April 16, 2008

Last Update Submit

November 30, 2020

Conditions

Keywords

Myocardial ViabilityDelayed Enhancement Magnetic Resonance ImagingFunctional Recovery

Outcome Measures

Primary Outcomes (1)

  • To examine whether the extent of irreversible myocardial injury as assessed by Delayed Enhancement Magnetic Resonance Imaging can predict the extent of functional recovery after revascularization in patients with chronic coronary artery disease (CAD).

    36 months

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients were recruited from 9 institutions on 3 different continent. All patients recruited for the study had a history of angiographically documented chronic coronary artery disease and resting wall motion abnormalities, and were scheduled for cardiac revascularization (coronary artery bypass surgery or percutaneous intervention).

You may qualify if:

  • Age: \> 21 years and \< 85 years
  • Sinus rhythm
  • Weight \< 120 kg
  • LVEF \> 30%
  • Wall motion abnormality on Echo. or LV-gram
  • Scheduled for revascularization - Angioplasty/Stent or CABG - within 30 days

You may not qualify if:

  • Resting heart rate \> 100 bpm
  • Frequent atrial or ventricular ectopy
  • Severe aortic stenosis or HOCM
  • Unstable angina
  • Myocardial infarction within 14 days
  • Active congestive heart failure
  • Pregnancy
  • Known allergy to gadolinium
  • Contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

St. Luke's Episcopal Location

Houston, Texas, 77030, United States

Location

Cliniques Universitaires St. Luc

Brussels, B-1200, Belgium

Location

Skejby University Hospital

Aarhus N, 8200, Denmark

Location

Hygeia Hospital

Marousi, 15123, Greece

Location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Cardiac MRI Unit

Leeds, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Scott D Flamm, M.D.

    CHI St. Luke's Health, Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 18, 2008

Study Start

August 11, 2003

Primary Completion

January 14, 2011

Study Completion

May 15, 2011

Last Updated

December 2, 2020

Record last verified: 2020-11

Locations