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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: regadenoson

• Registration Number: NCT01446094
• Lead Sponsor: Dipan Shah

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Aged 18 years or older
• Scheduled for invasive coronary angiography

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm	regadenoson	Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.

Primary Outcome Measures

Name	Time	Method
Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.	Up to 7 days	Evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a rapid regadenoson stress CMR protocol for the detection of \>= 70% stenosis of a major epicardial coronary artery on invasive coronary angiography.

Secondary Outcome Measures

Name	Time	Method
Evaluate time for performance of rapid regadenoson stress CMR protocol.	Up to 7 days	Evaluate duration of time for performance of rapid regadenoson stress CMR protocol in comparison to time for performance of standard regadenoson stress CMR protocol.

Trial Locations

Locations (1)

The Methodist Hospital; 🇺🇸 Houston, Texas, United States