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

Coronary Artery Disease Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT00622167
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Terminated
• Phase: N/A
• Start date: January 2008
• Completion date: June 2009