Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01592565
• Lead Sponsor: Ohio State University

Brief Summary

This study is being done to demonstrate a powerful new method for detecting heart disease that combines the proven prognostic capability of exercise stress testing with the superior image quality of Cardiac Magnetic Resonance Imaging (CMR). The investigators hope to demonstrate that exercise CMR has equivalent or superior diagnostic accuracy compared to exercise stress SPECT for detecting obstructive artery disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Primary Completion: 2014-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• any patient referred for stress SPECT
• known or suspected ischemic heart disease
• ability to perform adequate treadmill stress

Exclusion Criteria

• any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia)
• renal insufficiency (GFR < 40)
• known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA (computed tomography angiography) in patients not referred for cath after 2 weeks)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Exercise stress CMR has equivalent or superior diagnostic and prognostic value compared to exercise stress nuclear scintigraphy in patients suspected of CAD (coronary artery disease)	baseline	Exercise nuclear and CMR examinations including aggregate assessment of exercise parameters, ECG findings, myocardial perfusion, segmental left ventricular wall motion (CMR only), and viability will be independently reviewed offline by a consensus of two reviewers blinded to the results of the other imaging study, and each test will be classified as either negative/adequate stress, negative/inadequate stress, positive for ischemia, or fixed abnormality/no ischemia.

Trial Locations

Locations (3)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

The Lindner Center at The Christ Hospital; 🇺🇸 Cinncinatti, Ohio, United States

University Of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States