An interventional study of Integrated Backscatter IVUS and Dual Source Computed Tomography in Coronary Artery Disease, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-03.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic
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:
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 24 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exclusion criteria assessed during catheterization procedure
All patients will receive integrated backscatter IVUS and dual source CT.
Device: Integrated Backscatter IVUS · Device: Dual Source Computed Tomography
All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
All subjects have DSCT and IBIVUS imaging
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
Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.
| Milestone | IBIVUS and DSCT |
|---|---|
| Started | 24 |
| Completed | 4 |
| Not completed | 20 |
| Withdrew: Did not meet angiographic criteria | 20 |
Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IBIVUS and DSCT | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | IBIVUS and DSCT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 13 |
| Age Continuous(years) | IBIVUS and DSCT |
|---|---|
| Mean | NA ± NA |
| Sex: Female, Male(Participants) | IBIVUS and DSCT |
|---|---|
| Female | 3 |
| Male | 21 |
| Region of Enrollment(participants) | IBIVUS and DSCT |
|---|---|
| United States | 24 |
This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital