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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:
ClinicalTrials.gov Identifier:
NCT00622167
First Posted: February 22, 2008
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Results First Submitted: July 28, 2011  
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

  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were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.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 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   13 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 NA [1] 
[1] Study terminated after imaging 4 subjects due to slow enrollment. No analysis performed.
Gender 
[Units: Participants]
 
Female   3 
Male   21 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  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


  Limitations and Caveats
  Hide 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.


  More Information
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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
e-mail: imcnulty@partners.org



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