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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):
Victor Mor-Avi, University of Chicago
ClinicalTrials.gov Identifier:
NCT00857792
First received: March 5, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

Resource links provided by NLM:

Drug Information available for: Regadenoson
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857792

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

Publications:

Responsible Party: Victor Mor-Avi, Res Assoc (Professor), University of Chicago
ClinicalTrials.gov Identifier: NCT00857792     History of Changes
Other Study ID Numbers: 15237B
Study First Received: March 5, 2009
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
 Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013