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Trial record 21 of 123 for:    IK

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622167
Recruitment Status : Terminated (Subject recruitment was slow, so enrollment has been closed.)
First Posted : February 22, 2008
Results First Posted : February 3, 2012
Last Update Posted : February 3, 2012
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Integrated Backscatter IVUS Device: Dual Source Computed Tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622167

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

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Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Massachusetts General Hospital Identifier: NCT00622167     History of Changes
Other Study ID Numbers: 2007P001842
First Posted: February 22, 2008    Key Record Dates
Results First Posted: February 3, 2012
Last Update Posted: February 3, 2012
Last Verified: January 2012

Keywords provided by Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital:
Plaque characteristics

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