Coronary Artery Disease
Conditions
Keywords
Plaque characteristics, DSCT, IVUS
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.
Interventions
DEVICEIntegrated Backscatter IVUS
All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
DEVICEDual Source Computed Tomography
All subjects have DSCT and IBIVUS imaging
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound). | At time of imaging | Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition). |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.
Pre-assignment details
Subjects were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.
Participants by arm
| Arm | Count |
|---|---|
| IBIVUS and DSCT All patients will receive integrated backscatter IVUS and dual source CT. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet angiographic criteria | 20 |
Baseline characteristics
| Characteristic | IBIVUS and DSCT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age Continuous | NA years |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
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).
Time frame: At time of imaging
Population: Imaging 30 subjects was predicted to include enough plaques for analysis.
Comparison: Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.p-value: 0Not done