Trial Outcomes & Findings for Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease (NCT NCT00622167)

Results Overview

Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

At time of imaging

Results posted on

2012-02-03

Participant Flow

Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.

Subjects were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.

Participant milestones

Participant milestones
Measure	IBIVUS and DSCT All patients will receive integrated backscatter IVUS and dual source CT.
Overall Study STARTED	24
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	IBIVUS and DSCT All patients will receive integrated backscatter IVUS and dual source CT.
Overall Study Did not meet angiographic criteria	20

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IBIVUS and DSCT n=24 Participants All patients will receive integrated backscatter IVUS and dual source CT.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of imaging

Population: Imaging 30 subjects was predicted to include enough plaques for analysis.

Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).

Outcome measures

Outcome data not reported

Adverse Events

IBIVUS and DSCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Iris McNulty, RN

Massachusetts General Hospital

Phone: 617 726 2612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place