Stress CT Perfusion in Patients With Chest Pain

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01969916
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : October 27, 2017
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

Our hypothesis is that quantitative 3D analysis of cardiac CT images obtained during vasodilator stress can accurately identify patients presenting at the emergency department with acute chest pain due to underlying hemodynamically significant coronary stenosis, aid in the identification of individuals most likely to benefit from revascularization, and thus improve the ability to predict patient outcomes.

Our goals are:

  1. to test the above hypothesis by comparing stress MDCT perfusion data with invasive fractional flow reserve (FFR) data in patients with significant stenosis who undergo ICA;
  2. to determine the added value of MDCT perfusion as an adjunct to CTCA for predicting patient outcomes.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comprehensive Evaluation of Patients With Chest Pain Using Cardiac Computed Tomography: Value of Adding Regadenoson Stress Perfusion Imaging to Noninvasive Coronary Angiography
Study Start Date : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain
Drug Information available for: Regadenoson
U.S. FDA Resources

Arm Intervention/treatment
Regadenoson Drug: Regadenoson
Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
Other Name: Lexiscan

Primary Outcome Measures :
  1. Ability to detect stress-induced perfusion abnormalities by 3D analysis of MDCT images [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patients with chest pain referred for CT coronary angiography

Exclusion Criteria:

  • allergy to iodine,
  • renal dysfunction (creatinine >1.6 mg/dL)
  • chronic obstructive pulmonary disease
  • advanced heart block
  • or systolic blood pressure <90 mmHg

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 identifier (NCT number): NCT01969916

Contact: Victor Mor-Avi, Ph.D. 773-702-7780
Contact: Amit R. Patel, M.D. 773-834-3363

United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Victor Mor-Avi   
Principal Investigator: Amit R. Patel, M.D.         
Sponsors and Collaborators
University of Chicago
Astellas Pharma Inc
Principal Investigator: Victor Mor-Avi, Ph.D. University of Chicago


Responsible Party: University of Chicago Identifier: NCT01969916     History of Changes
Other Study ID Numbers: 15237B-AM005
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by University of Chicago:
Cardiac CT imaging
Myocardial ischemia
Myocardial perfusion
Vasodilator stress testing

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Chest Pain
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs