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Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by The Methodist Hospital System
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Dipan Shah, The Methodist Hospital System Identifier:
First received: September 21, 2011
Last updated: October 3, 2016
Last verified: October 2016
This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.

Condition Intervention Phase
Coronary Artery Disease
Drug: regadenoson
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR. [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a rapid regadenoson stress CMR protocol for the detection of >= 70% stenosis of a major epicardial coronary artery on invasive coronary angiography.

Secondary Outcome Measures:
  • Evaluate time for performance of rapid regadenoson stress CMR protocol. [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    Evaluate duration of time for performance of rapid regadenoson stress CMR protocol in comparison to time for performance of standard regadenoson stress CMR protocol.

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.
Drug: regadenoson
Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.
Other Name: Lexiscan

Detailed Description:
This is a single center, open-label, pilot study in subjects scheduled for invasive coronary angiography for evaluation of coronary artery disease. The primary objective is to evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a novel rapid regadenoson stress CMR protocol for detection of >= 70 coronary artery stenosis on invasive coronary angiography. Additionally the objective will be to compare the time for performance of this novel rapid regadenoson stress CMR protocol in comparison to the standard stress CMR protocol.

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

Inclusion Criteria:

  • Aged 18 years or older
  • Scheduled for invasive coronary angiography

Exclusion Criteria:

  • Inability to give informed consent
  • Possible pregnancy (confirmed by urine test)
  • Women who are breastfeeding
  • Severe claustrophobia
  • Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)
  • Individuals with cochlear implants
  • Individuals with non-MRI compatible aneurysm clips
  • Potential contraindications to regadenoson use due to:

Severe lung disease (active wheezing) Severe bradycardia (heart rate < 40 beats/min) Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT syndrome Severe hypotension (systolic BP < 80 mm Hg) Decompensated heart failure

  • Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):

Stage 4 or 5 chronic kidney disease (eGFR < 30 ml/min/1.73 m2) Known allergy to GBCA

Special Considerations:

- Although individuals who have an occupational history of welding, grinding, or other metal work will not be excluded from the study, they must undergo an orbital x-ray, to exclude any occult metal fragments, before they can participate in this study.

  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: NCT01446094

Contact: Mohaman Ghosn, PhD 713-441-9837
Contact: Tatiana Belousova, MD 713-441-6536

United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ghosn Mohamad, PhD    713-441-9837   
Principal Investigator: Dipan J Shah, MD         
Sub-Investigator: Neal S Kleiman, MD         
Sub-Investigator: Faisal Nabi, MD         
Sub-Investigator: Kamran Shaikh, MD         
Sponsors and Collaborators
Dipan Shah
Astellas Pharma Global Development, Inc.
Principal Investigator: Dipan Shah, M.D. The Methodist Hospital System
  More Information


Responsible Party: Dipan Shah, Director, Cardiac Magnetic Resonance Imaging, The Methodist Hospital System Identifier: NCT01446094     History of Changes
Other Study ID Numbers: Pro00006077  IRB(2)0511-0092 
Study First Received: September 21, 2011
Last Updated: October 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Plan to share data to be determined.

Keywords provided by The Methodist Hospital System:
Coronary artery disease

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 October 20, 2016