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Trial record 21 of 123 for:    IK

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

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ClinicalTrials.gov Identifier: NCT00622167
Recruitment Status : Terminated (Subject recruitment was slow, so enrollment has been closed.)
First Posted : February 22, 2008
Results First Posted : February 3, 2012
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Interventions Device: Integrated Backscatter IVUS
Device: Dual Source Computed Tomography
Enrollment 24
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were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.
Arm/Group Title IBIVUS and DSCT
Hide Arm/Group Description All patients will receive integrated backscatter IVUS and dual source CT.
Period Title: Overall Study
Started 24
Completed 4
Not Completed 20
Reason Not Completed
Did not meet angiographic criteria             20
Arm/Group Title IBIVUS and DSCT
Hide Arm/Group Description All patients will receive integrated backscatter IVUS and dual source CT.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  45.8%
>=65 years
13
  54.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
NA [1]   (NA)
[1]
Study terminated after imaging 4 subjects due to slow enrollment. No analysis performed.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
3
  12.5%
Male
21
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
Hide Description Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
Time Frame At time of imaging
Hide Outcome Measure Data
Hide Analysis Population Description
Imaging 30 subjects was predicted to include enough plaques for analysis.
Arm/Group Title Plaque Characteristics
Hide Arm/Group Description:
Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.
Overall Number of Participants Analyzed 0
Overall Number of Units Analyzed
Type of Units Analyzed: Plaques
0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Total number of subjects at risk=4 since 20 subjects were screen failures and did not have any study imaging.
 
Arm/Group Title IBIVUS and DSCT
Hide Arm/Group Description All patients will receive integrated backscatter IVUS and dual source CT.
All-Cause Mortality
IBIVUS and DSCT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IBIVUS and DSCT
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IBIVUS and DSCT
Affected / at Risk (%)
Total   0/4 (0.00%) 
Study terminated after imaging 4 subjects due to slow enrollment. Results will not be analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Iris McNulty, RN
Organization: Massachusetts General Hospital
Phone: 617 726 2612
Responsible Party: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00622167     History of Changes
Other Study ID Numbers: 2007P001842
First Submitted: February 12, 2008
First Posted: February 22, 2008
Results First Submitted: July 28, 2011
Results First Posted: February 3, 2012
Last Update Posted: February 3, 2012