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

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Backscatter IVUS
Dual Source Computed Tomography
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Plaque characteristics, DSCT, IVUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

All patients will receive integrated backscatter IVUS and dual source CT.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 12, 2008
Last Updated
January 3, 2012
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00622167
Brief Title
Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Subject recruitment was slow, so enrollment has been closed.
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Plaque characteristics, DSCT, IVUS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
All patients will receive integrated backscatter IVUS and dual source CT.
Intervention Type
Device
Intervention Name(s)
Integrated Backscatter IVUS
Intervention Description
All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
Intervention Type
Device
Intervention Name(s)
Dual Source Computed Tomography
Intervention Description
All subjects have DSCT and IBIVUS imaging
Primary Outcome Measure Information:
Title
Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
Description
Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
Time Frame
At time of imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ik-Kyung Jang, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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