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Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00857792
First received: March 5, 2009
Last updated: May 9, 2016
Last verified: May 2016
Results First Received: November 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Coronary Disease
Intervention: Drug: regadenoson

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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 
COMPLETED   108 
NOT COMPLETED   12 
inadequate image quality for analysis                12 



  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.
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Reporting Groups
  Description
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]
 120 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (11) 
Gender 
[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
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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
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  More Information
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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
e-mail: vmoravi@bsd.uchicago.edu


Publications:


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00857792     History of Changes
Other Study ID Numbers: 15237B
Study First Received: March 5, 2009
Results First Received: November 18, 2014
Last Updated: May 9, 2016
Health Authority: United States: Food and Drug Administration