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

Mass General Brigham

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Device: Dual Source Computed Tomography; Device: Integrated Backscatter IVUS

Study type: Interventional

Funder types: Other

Identifiers

NCT00622167

2007P001842

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Other group

Description:

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

Treatment:

Device: Dual Source Computed Tomography

Device: Integrated Backscatter IVUS