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Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

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ClinicalTrials.gov 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

Brief Summary:

The investigators goals are:

  1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images
  2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns
  3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.

Condition or disease Intervention/treatment Phase
Coronary Disease Drug: regadenoson Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging
Study Start Date : March 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Open Label Drug: regadenoson
Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
Other Name: Lexiscan

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years and older
  • Subjects referred for clinically indicated cardiac CT exams

Exclusion Criteria:

  • Subjects with a history of lung disease
  • Pregnant subjects
  • Subjects with second or third degree AV block or sinus node dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857792

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Astellas Pharma Inc
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Principal Investigator: Victor Mor-Avi, PhD University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00857792    
Other Study ID Numbers: 15237B
First Posted: March 9, 2009    Key Record Dates
Results First Posted: December 2, 2014
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by University of Chicago:
Coronary Disease
Cardiac CT Imaging
Stress Testing
Lexiscan (regadenoson)
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs