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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dipan Shah
• Collaborator: Astellas Pharma Global Development, Inc.
• Treatments: Regadenoson

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.