Clinical trial NCT00622167: Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Plaque characteristics
DSCT
IVUS
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

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

Primary outcomes:
measure: Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
timeFrame: At time of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ik-Kyung Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: