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

January 3, 2012 updated by: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At time of imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

January 3, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P001842

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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