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

February 12, 2008
January 3, 2012
January 2008
April 2008   (final data collection date for primary outcome measure)
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).
Comparison of plaque characteristics between DSCT and IVUS. [ Time Frame: At time of imaging ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00622167 on ClinicalTrials.gov Archive Site
Not Provided
Integrated backscatter IVUS plaque characteristics and their relation to biomarker elevation post PCI. [ Time Frame: At time of imaging ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
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).

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • 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
1
All patients will receive integrated backscatter IVUS and dual source CT.
Interventions:
  • Device: Integrated Backscatter IVUS
  • Device: Dual Source Computed Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
June 2009
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00622167
2007P001842
No
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP