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

Massachusetts General Hospital24 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Integrated Backscatter IVUSDEVICE

All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.

Dual Source Computed TomographyDEVICE

All subjects have DSCT and IBIVUS imaging

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: At time of imaging

Data from ClinicalTrials.gov

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