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Exercise Cardiac Magnetic Resonance Imaging Accuracy for Cardiovascular Stress Testing

An In-state Multi-center Evaluation of Treadmill Exercise Stress Cardiac Magnetic Resonance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01592565
Acronym
EXACT
Enrollment
227
Registered
2012-05-07
Start date
2010-08-31
Completion date
Unknown
Last updated
2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

Cardiac Magnetic Resonance (CMR) offers superior image quality compared to echocardiography and nuclear imaging, and the ability to image both function and perfusion. Combining the superior image quality of CMR with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease. This project is expected to show that CMR is at least equivalent to nuclear stress imaging and could potentially replace it in many instances, eliminating the need for radioisotope administration and the associated exposure of patients to ionizing radiation.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
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)baselineExercise 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026