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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.
Verified September 2017 by Dipan Shah, The Methodist Hospital System
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446094
First Posted: October 4, 2011
Last Update Posted: October 3, 2017
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.
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Dipan Shah, The Methodist Hospital System
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 Dipan Shah, 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 ]
    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 ]
    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 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single-arm
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.
  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01446094


Contacts
Contact: Mohaman Ghosn, PhD 713-441-9837 mghosn@houstonmethodist.org

Locations
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Ghosn Mohamad, PhD    713-441-9837    mghosn@houstonmethodist.org   
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.
Investigators
Principal Investigator: Dipan Shah, M.D. The Methodist Hospital System
  More Information

Publications:

Responsible Party: Dipan Shah, Director, Cardiac Magnetic Resonance Imaging, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01446094     History of Changes
Other Study ID Numbers: Pro00006077
IRB(2)0511-0092 ( Other Identifier: HMRI IRB )
First Submitted: September 21, 2011
First Posted: October 4, 2011
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share data to be determined.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dipan Shah, The Methodist Hospital System:
Coronary artery disease

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 Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs