Stress Testing and Cardiac Magnetic Resonance

July 8, 2021 updated by: University of Chicago
The purpose of this study is to better define the role of a comprehensive stress MRI (which includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar imaging) in medical practice and in patient health management. Information gathered from the healthy volunteers that participate in this study will be compared to information from the coronary artery disease patients in this study in order to help further our understanding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary artery disease is a major cause of morbidity and mortality in the United States. Currently, the presence of physiologically significant coronary disease is most commonly diagnosed using non-invasive imaging tests such as a nuclear stress test or an echo stress test. Unfortunately, nuclear stress tests require the use of ionizing radiation and have a limited spatial resolution. On the other hand, echo stress tests are dependent of adequate imaging windows. Adenosine stress testing combined with cardiac magnetic resonance (CMR) is a rapidly evolving technique for diagnosing significant coronary disease. It does not use ionizing radiation and has excellent image quality. In a recent meta-analysis of 14 studies with a total of 1,183 patients, the sensitivity and specificity of stress CMR for detecting significant coronary disease was 91% and 81%. Additionally, 2 studies have shown that patients with a normal stress CMR study have a <1% risk of having a cardiovascular event during the ensuing year. Another important advantage to stress CMR is the ability to fully quantify myocardial blood flow which may improve the diagnostic accuracy of stress CMR. In addition to perfusion imaging, CMR can directly visualize the coronary arteries, detect extremely small myocardial infarctions, and precisely measure the left ventricular function.

Although adenosine stress CMR is a rapidly maturing test, several important challenges exist. First, many patients find it difficult to tolerate the common side effects of adenosine in the confined space of the MRI scanner. Secondly, many patients under the influence of adenosine and its side effects cannot adequately hold their breath during image acquisition making image interpretation more difficult and quantitative analysis very time consuming. Finally, because adenosine must be continuously infused during a contrast-enhanced stress CMR, 2 separate intravenous (I.V.) catheters are needed. Most of the undesirable effects of adenosine are mediated through the adenosine A(2B) and A(3) receptors; where as, its desired vasodilator effects are mediated through the A(2A) receptor. The FDA recently approved an adenosine A(2A) receptor specific stress testing agent called regadenoson which is administered as a 10 second bolus and has an improved side effect and safety profile when compared to adenosine. With its improved tolerability and ease of use, regadenoson is a more ideal stress testing agent to use with CMR.

The purpose of this study is to determine whether a comprehensive regadenoson stress cardiac magnetic resonance study which includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar imaging provides incremental prognostic information over a clinical evaluation that includes nuclear stress testing.

Study Type

Interventional

Enrollment (Actual)

20

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

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:

  • Suspected coronary artery disease
  • Symptoms of possible coronary artery disease

Exclusion Criteria:

  • Acute ST-elevation myocardial infarction
  • Second or third degree AV block
  • Severe Renal Disease (Glomerular Filtration Rate (GFR) <30cc/min or hemodialysis)
  • Contra-indications to MRI (i.e. Implantable Cardioverter Defibrillator (ICD), pacemaker, aneurysm clip, etc)
  • Hemodynamic instability
  • Inability to provide informed consent
  • Severe claustrophobia
  • Pregnancy
  • Age <18 years

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open Label
Approximately 25 healthy volunteers will be recruited as controls. Scan will be done with regadenoson contrast.
Drug: regadenoson
Subjects in open label group will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus) as contrast.
Other Names:
  • Lexiscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: 3 years
Major adverse cardiovascular events, such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship Between SPECT and CMR Results of Myocardial Perfusion Imaging
Time Frame: 1 year
Relationship between SPECT and CMR results of myocardial perfusion imaging for 1 Year
1 year
Optimization of Coronary Imaging Using CMR
Time Frame: 1 year
Optimization of coronary imaging using CMR for 1 Year
1 year

Collaborators and Investigators

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

Sponsor

University of Chicago

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Amit Patel, M.D., University of Chicago

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

April 1, 2009

Primary Completion (Actual)

June 4, 2014

Study Completion (Actual)

June 4, 2014

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16570B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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