Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT00622167|
Recruitment Status : Terminated (Subject recruitment was slow, so enrollment has been closed.)
First Posted : February 22, 2008
Results First Posted : February 3, 2012
Last Update Posted : February 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Integrated Backscatter IVUS Device: Dual Source Computed Tomography||Not Applicable|
The primary objectives of this study are:
- To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
- To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter & area measurements & plaque volume.
- To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
- To evaluate the ability of DSCT to identify & measure lesion remodeling compared to gray-scale IVUS.
- To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||June 2009|
All patients will receive integrated backscatter IVUS and dual source CT.
Device: Integrated Backscatter IVUS
All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
Device: Dual Source Computed Tomography
All subjects have DSCT and IBIVUS imaging
- Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound). [ Time Frame: At time of imaging ]Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
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): NCT00622167
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Ik-Kyung Jang, MD, PhD||Massachusetts General Hospital|