Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System
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|ClinicalTrials.gov Identifier: NCT03103061|
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Coronary Artery Disease||Drug: Lexiscan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Stress and rest perfusion imaging using Lexiscan as the coronary vasodilator (pharmacological stressor).|
|Masking:||None (Open Label)|
|Official Title:||Use of Lexiscan for Myocardial Stress Perfusion Computed Tomography With a 3rd Generation Dual Source CT System|
|Actual Study Start Date :||February 9, 2016|
|Actual Primary Completion Date :||June 14, 2018|
|Actual Study Completion Date :||June 14, 2018|
Experimental: Myocardial Stress CT Perfusion
Low-radiation, dynamic perfusion CT of the heart in patients with suspected ischemic chest pain and a moderate or severe stenosis seen on coronary CTA. Lexiscan(TM) will be used as the pharmacological stress agent (coronary vasodilator).
- Number of Treatment-related Adverse Events [ Time Frame: 30 days +/- 3 days ]
Demonstrate that CTA with stress and rest perfusion imaging using Lexiscan as the coronary vasodilator will be safe and well tolerated.
This outcome measure data value represents the number of adverse events that occurred during this study.
- Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment [ Time Frame: Immediately following CT perfusion imaging. ]Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103061
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|