Multicenter Myocardial Viability Trial

NCT ID: NCT00661232

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-11

Study Completion Date

2011-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

CHI St. Luke's Health, Texas

OTHER

Sponsor Role lead

Responsible Party

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Scott D. Flamm, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott D Flamm, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHI St. Luke's Health, Texas

Locations

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St. Luke's Episcopal Hospital

Houston, Texas, United States

Site Status

St. Luke's Episcopal Location

Houston, Texas, United States

Site Status

Cliniques Universitaires St. Luc

Brussels, , Belgium

Site Status

Skejby University Hospital

Aarhus N, , Denmark

Site Status

Hygeia Hospital

Marousi, , Greece

Site Status

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Cardiac MRI Unit

Leeds, , United Kingdom

Site Status

Countries

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United States Belgium Denmark Greece Thailand United Kingdom

Other Identifiers

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NDA# 20-937

Identifier Type: -

Identifier Source: secondary_id

IND# 66,506

Identifier Type: -

Identifier Source: secondary_id

1102-02-777

Identifier Type: -

Identifier Source: org_study_id

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