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

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. 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
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

  Participant Flow

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were consented prior to cardiac catheterization, and if they did not meet angiographic inclusion criteria they were withdrawn from the study.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
IBIVUS and DSCT All patients will receive integrated backscatter IVUS and dual source CT.

Participant Flow:   Overall Study
Did not meet angiographic criteria                20 

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   13 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 NA [1] 
[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

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

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 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