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

Dipan Shah

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: regadenoson

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01446094

IRB(2)0511-0092 (Other Identifier)

Pro00006077

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.