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

Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01446094

Enrollment

Registered

2011-10-04

Start date

2011-08-31

Completion date

2018-06-30

Last updated

2017-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

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.

Interventions

DRUGregadenoson

Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactMohaman Ghosn, PhD

mghosn@houstonmethodist.org713-441-9837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026