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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

regadenoson

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single-arm

Arm Description

Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.

Outcomes

Primary Outcome Measures

Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.

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.

Evaluate duration of time for performance of rapid regadenoson stress CMR protocol in comparison to time for performance of standard regadenoson stress CMR protocol.

Full Information

NCT ID

NCT01446094

First Posted

September 21, 2011

Last Updated

September 29, 2017

Sponsor

Dipan Shah

Collaborators

Astellas Pharma Global Development, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01446094

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dipan Shah

Collaborators

Astellas Pharma Global Development, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary artery disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single-arm

Arm Type

Other

Arm Description

Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.

Intervention Type

Drug

Intervention Name(s)

regadenoson

Other Intervention Name(s)

Lexiscan

Intervention Description

Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.

Primary Outcome Measure Information:

Title

Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.

Description

Time Frame

Up to 7 days

Secondary Outcome Measure Information:

Title

Evaluate time for performance of rapid regadenoson stress CMR protocol.

Description

Evaluate duration of time for performance of rapid regadenoson stress CMR protocol in comparison to time for performance of standard regadenoson stress CMR protocol.

Time Frame

Up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohaman Ghosn, PhD

Phone

713-441-9837

mghosn@houstonmethodist.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dipan Shah, M.D.

Organizational Affiliation

The Methodist Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ghosn Mohamad, PhD

Phone

713-441-9837

mghosn@houstonmethodist.org

First Name & Middle Initial & Last Name & Degree

Dipan J Shah, MD

First Name & Middle Initial & Last Name & Degree

Neal S Kleiman, MD

First Name & Middle Initial & Last Name & Degree

Faisal Nabi, MD

First Name & Middle Initial & Last Name & Degree

Kamran Shaikh, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Plan to share data to be determined.

Citations:

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12573373

Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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

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