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

NCT ID: NCT00622167

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-06-30

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:

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: OTHER

Integrated Backscatter IVUS

Intervention Type: DEVICE

All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.

Dual Source Computed Tomography

Intervention Type: DEVICE

All subjects have DSCT and IBIVUS imaging

Interventions

Integrated Backscatter IVUS

All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.

Intervention Type: DEVICE

Dual Source Computed Tomography

All subjects have DSCT and IBIVUS imaging

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ik-Kyung Jang, MD, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ik-Kyung Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2007P001842

Identifier Type: -

Identifier Source: org_study_id