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Subject recruitment was slow, so enrollment has been closed.
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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).
The primary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | All patients will receive integrated backscatter IVUS and dual source CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Backscatter IVUS | Device | All subjects have Integrated Backscatter IVUS and Dual Source CT imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria assessed during catheterization procedure
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| Name | Affiliation | Role |
|---|---|---|
| Ik-Kyung Jang, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Subjects were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.
Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | IBIVUS and DSCT | All patients will receive integrated backscatter IVUS and dual source CT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IBIVUS and DSCT | All patients will receive integrated backscatter IVUS and dual source CT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Imaging 30 subjects was predicted to include enough plaques for analysis. | Posted | Number | plaques | At time of imaging | Plaques | Participants |
|
|
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Total number of subjects at risk=4 since 20 subjects were screen failures and did not have any study imaging.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IBIVUS and DSCT | All patients will receive integrated backscatter IVUS and dual source CT. |
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Study terminated after imaging 4 subjects due to slow enrollment. Results will not be analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iris McNulty, RN | Massachusetts General Hospital | 617 726 2612 | imcnulty@partners.org |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Dual Source Computed Tomography | Device | All subjects have DSCT and IBIVUS imaging |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Plaques |
|
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| 0 |
| 4 |
| 0 |
| 4 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |