Stress CT Perfusion in Patients With Chest Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Chicago
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01969916
First received: October 21, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention
Coronary Artery 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: Comprehensive Evaluation of Patients With Chest Pain Using Cardiac Computed Tomography: Value of Adding Regadenoson Stress Perfusion Imaging to Noninvasive Coronary Angiography

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Ability to detect stress-induced perfusion abnormalities by 3D analysis of MDCT images [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Regadenoson Drug: Regadenoson
Patients will be given a single dose of Lexiscan (0.4 mg, iv 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:

  • patients with acute chest pain referred by the emergency department 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
  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 ClinicalTrials.gov identifier: NCT01969916

Contacts
Contact: Victor Mor-Avi, Ph.D. 773-702-7780 vmoravi@bsd.uchicago.edu
Contact: Amit R. Patel, M.D. 773-834-3363 apatel2@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Victor Mor-Avi       vmoravi@bsd.uchicago.edu   
Principal Investigator: Amit R. Patel, M.D.         
Sponsors and Collaborators
University of Chicago
Astellas Pharma Inc
Investigators
Principal Investigator: Victor Mor-Avi, Ph.D. University of Chicago
  More Information

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01969916     History of Changes
Other Study ID Numbers: 15237B-AM005
Study First Received: October 21, 2013
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Chest Pain
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pain
Signs and Symptoms
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 July 24, 2014