Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease|
- Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR. [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]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.
- Evaluate time for performance of rapid regadenoson stress CMR protocol. [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]Evaluate duration of time for performance of rapid regadenosone stress CMR protocol in comparison to time for performance of standard regadenoson stress CMR protocol.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
|United States, Texas|
|The Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Dawn Elliot 713-441-6536 email@example.com|
|Contact: Mary Mata 713-441-5981 firstname.lastname@example.org|
|Principal Investigator: Dipan J Shah, MD|
|Sub-Investigator: Neal S Kleiman, MD|
|Sub-Investigator: Faisal Nabi, MD|
|Sub-Investigator: Kamran Shaikh, MD|
|Principal Investigator:||Dipan Shah, M.D.||The Methodist Hospital System|