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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Integrated Backscatter IVUS
* Device: Dual Source Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or non-pregnant females > / = 18 years of age Scheduled for coronary angiography Exclusion Criteria: Acute ST-elevation myocardial infarction within last 72 hours Current congestive heart failure Current cardiogenic shock Unstable clinical condition Known cardiomyopathy (EF < 30%) Creatinine >1.5 mg/dL Definite allergy to iodinated contrast media Current participation in an investigational drug or device research study HR > 65 and contraindications to the administration of beta blockers Exclusion criteria assessed during catheterization procedure PCI of native coronary vessel not performed Left main stenosis > 50% Any vessel contraindicated for IVUS imaging Any lesion contraindicated for IVUS imaging Inability to pass IVUS catheter PCI of bifurcation lesion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>All patients will receive integrated backscatter IVUS and dual source CT. | Device: Integrated Backscatter IVUS<br>* All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.<br>Device: Dual Source Computed Tomography<br>* All subjects have DSCT and IBIVUS imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound). | Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition). | At time of imaging | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque characteristics, DSCT, IVUS