Trial | NCT01446094  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
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 Started
Aug 31
2011
Primary Completion
Jun 30
2018
Anticipated
Study Completion
Jun 30
2018
Anticipated
Last Update
Oct 03
2017

Drug regadenoson

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

  • Other names: Lexiscan

single-arm Other

Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, 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.
No Results Posted