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Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

This study has been completed.
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: March 5, 2009
Last updated: May 9, 2016
Last verified: May 2016

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 Intervention
Coronary Disease Drug: regadenoson

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

Resource links provided by NLM:

Further study details as provided by University of Chicago:

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

Enrollment: 120
Study Start Date: March 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00857792

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


Responsible Party: University of Chicago 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

Keywords provided by University of Chicago:
Coronary Disease
Cardiac CT Imaging
Stress Testing
Lexiscan (regadenoson)

Additional relevant MeSH terms:
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 processed this record on August 18, 2017