Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/5/2017
Start Date:August 2011
End Date:June 2018
Contact:Mohaman Ghosn, PhD
Email:mghosn@houstonmethodist.org
Phone:713-441-9837

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Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease

This study is designed to evaluate the feasibility and diagnostic performance of a novel
rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.

This is a single center, open-label, pilot study in subjects scheduled for invasive coronary
angiography for evaluation of coronary artery disease. The primary objective is to evaluate
the profile of sensitivity, specificity, and diagnostic accuracy of a novel rapid regadenoson
stress CMR protocol for detection of >= 70 coronary artery stenosis on invasive coronary
angiography. Additionally the objective will be to compare the time for performance of this
novel rapid regadenoson stress CMR protocol in comparison to the standard stress CMR
protocol.

Inclusion Criteria:

- Aged 18 years or older

- Scheduled for invasive coronary angiography

Exclusion Criteria:

- Inability to give informed consent

- Possible pregnancy (confirmed by urine test)

- Women who are breastfeeding

- Severe claustrophobia

- Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete
the MRI procedure)

- Individuals with cochlear implants

- Individuals with non-MRI compatible aneurysm clips

- Potential contraindications to regadenoson use due to:

Severe lung disease (active wheezing) Severe bradycardia (heart rate < 40 beats/min)
Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT
syndrome Severe hypotension (systolic BP < 80 mm Hg) Decompensated heart failure

- Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):

Stage 4 or 5 chronic kidney disease (eGFR < 30 ml/min/1.73 m2) Known allergy to GBCA

Special Considerations:

- Although individuals who have an occupational history of welding, grinding, or other
metal work will not be excluded from the study, they must undergo an orbital x-ray, to
exclude any occult metal fragments, before they can participate in this study.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Dipan J Shah, MD
Phone: 713-441-9837
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Houston, TX
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