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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00622167
• Other study ID #: 2007P001842
• Status: Terminated
• Phase: N/A
• First received: February 12, 2008
• Last updated: January 3, 2012
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Integrated Backscatter IVUS
All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
• Dual Source Computed Tomography
All subjects have DSCT and IBIVUS imaging

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At time of imaging	No