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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by The Methodist Hospital System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01446094
First received: September 21, 2011
Last updated: May 21, 2012
Last verified: May 2012
  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: 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 regadenosone 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: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Regadenoson
    Intravenous administration of 0.4 mg dose of Regadenoson 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01446094

Locations
United States, Texas
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Dawn Elliot    713-441-6536    daelliot@tmhs.org   
Contact: Mary Mata    713-441-5981    mamata@tmhs.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
The Methodist Hospital System
Astellas Pharma Global Development, Inc.
Investigators
Principal Investigator: Dipan Shah, M.D. The Methodist Hospital System
  More Information

Publications:

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01446094     History of Changes
Other Study ID Numbers: IRB(2)0511-0092
Study First Received: September 21, 2011
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board

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
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014