Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
|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).
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|