Status:
UNKNOWN
Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease
Lead Sponsor:
Dipan Shah
Collaborating Sponsors:
Astellas Pharma Global Development, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Aged 18 years or older
- Scheduled for invasive coronary angiography
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01446094
Start Date
August 1 2011
End Date
June 1 2018
Last Update
October 3 2017
Active Locations (1)
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1
The Methodist Hospital
Houston, Texas, United States, 77030