Clinical trial NCT01446094: Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease
Official title: Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Global Development, Inc.
First posted: 2011-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.
timeFrame: Up to 7 days
Secondary outcomes:
measure: Evaluate time for performance of rapid regadenoson stress CMR protocol.
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Dipan Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
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