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

This study has been terminated.
(Subject recruitment was slow, so enrollment has been closed.)
Sponsor:
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00622167
First received: February 12, 2008
Last updated: January 3, 2012
Last verified: January 2012
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Coronary Artery Disease
Interventions: Device: Integrated Backscatter IVUS
Device: Dual Source Computed Tomography

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from January 2008 until September 2008. The study ended early due to slow enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.

Reporting Groups
  Description
IBIVUS and DSCT All patients will receive integrated backscatter IVUS and dual source CT.

Participant Flow:   Overall Study
    IBIVUS and DSCT  
STARTED     24  
COMPLETED     4  
NOT COMPLETED     20  
Did not meet angiographic criteria                 20  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IBIVUS and DSCT All patients will receive integrated backscatter IVUS and dual source CT.

Baseline Measures
    IBIVUS and DSCT  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     13  
Age  
[units: years]
Mean ± Standard Deviation
  NA  ± NA [1]
Gender  
[units: participants]
 
Female     3  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     24  
[1] Study terminated after imaging 4 subjects due to slow enrollment. No analysis performed.



  Outcome Measures

1.  Primary:   Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).   [ Time Frame: At time of imaging ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated after imaging 4 subjects due to slow enrollment. Results will not be analyzed.  


Results Point of Contact:  
Name/Title: Iris McNulty, RN
Organization: Massachusetts General Hospital
phone: 617 726 2612
e-mail: imcnulty@partners.org


No publications provided


Responsible Party: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00622167     History of Changes
Other Study ID Numbers: 2007P001842
Study First Received: February 12, 2008
Results First Received: July 28, 2011
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board