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

This study has been terminated.
(Subject recruitment was slow, so enrollment has been closed.)
Sponsor:
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00622167
First received: February 12, 2008
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention
Coronary Artery Disease
 Device: Integrated Backscatter IVUS
Device: Dual Source Computed Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound). [ Time Frame: At time of imaging ] [ Designated as safety issue: No ]
    Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).


Enrollment: 24
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622167

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00622167     History of Changes
Other Study ID Numbers: 2007P001842
Study First Received: February 12, 2008
Results First Received: July 28, 2011
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Plaque characteristics
DSCT
IVUS

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013