Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-03 @ 9:23 AM
Study NCT ID:
NCT00622167
Status:
TERMINATED
Last Update Posted:
2012-02-03
First Post:
2008-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Subject recruitment was slow, so enrollment has been closed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).
Detailed Description:
The primary objectives of this study are:
1. To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
2. To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter \& area measurements \& plaque volume.
3. To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
4. To evaluate the ability of DSCT to identify \& measure lesion remodeling compared to gray-scale IVUS.
5. 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.
1. To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
2. To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter \& area measurements \& plaque volume.
3. To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
4. To evaluate the ability of DSCT to identify \& measure lesion remodeling compared to gray-scale IVUS.
5. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: