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

September 29, 2017 updated by: Dipan Shah

Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital
        • Contact:
        • Sub-Investigator:
          • Neal S Kleiman, MD
        • Sub-Investigator:
          • Faisal Nabi, MD
        • Sub-Investigator:
          • Kamran Shaikh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • Lexiscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dipan Shah

Collaborators

Astellas Pharma Global Development, Inc.

Investigators

  • Principal Investigator: Dipan Shah, M.D., The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (ESTIMATE)

October 4, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00006077
  • IRB(2)0511-0092 (OTHER: HMRI IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plan to share data to be determined.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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