Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

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: NCT00857792
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : December 2, 2014
Last Update Posted : May 11, 2016
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Coronary Disease
Intervention: Drug: regadenoson

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Open Label regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).

Participant Flow:   Overall Study
    Open Label
STARTED   120 
inadequate image quality for analysis                12 

  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
Open Label regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).

Baseline Measures
   Open Label 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 54  (11) 
[Units: Participants]
Female   46 
Male   74 
Region of Enrollment 
[Units: Participants]
United States   120 

  Outcome Measures

1.  Primary:   Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.   [ Time Frame: 3 months ]

  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
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Victor Mor-Avi
Organization: The University of Chicago Medical Center
phone: 773-702-7780


Responsible Party: University of Chicago Identifier: NCT00857792     History of Changes
Other Study ID Numbers: 15237B
First Submitted: March 5, 2009
First Posted: March 9, 2009
Results First Submitted: November 18, 2014
Results First Posted: December 2, 2014
Last Update Posted: May 11, 2016