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Stress Testing and Cardiac Magnetic Resonance

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00871260
Collaborator
Astellas Pharma Inc (Industry)
20
Enrollment
1
Location
1
Arm
62.1
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Stress Testing and Cardiac Magnetic Resonance
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jun 4, 2014
Actual Study Completion Date :
Jun 4, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major Adverse Cardiovascular Events [3 years]

      Major adverse cardiovascular events, such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident.

    Secondary Outcome Measures

    1. Relationship Between SPECT and CMR Results of Myocardial Perfusion Imaging [1 year]

      Relationship between SPECT and CMR results of myocardial perfusion imaging for 1 Year

    2. Optimization of Coronary Imaging Using CMR [1 year]

      Optimization of coronary imaging using CMR for 1 Year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago
    • Astellas Pharma Inc

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00871260
    Other Study ID Numbers:
    • 16570B
    First Posted:
    Mar 30, 2009
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Chicago
    Coronary Disease
    Stress Testing
    Lexiscan (regadenoson)
    Cardiac Magnetic Resonance Imaging
    Additional relevant MeSH terms:
    Coronary Disease
    Coronary Artery Disease
    Regadenoson

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Healthy Patients
    Arm/Group Description Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
    Period Title: Overall Study
    STARTED 20
    COMPLETED 20
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Healthy Patients
    Arm/Group Description Due to low enrollment, twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery. All analyzes were based upon current enrollment.
    Overall Participants 20
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    32
    (13)
    Sex: Female, Male (Count of Participants)
    Female
    12
    60%
    Male
    8
    40%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    12
    60%
    Not Caucasian
    8
    40%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.
    Arm/Group Title Healthy Patients
    Arm/Group Description Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
    Measure Participants 20
    Count of Participants [Participants]
    0
    0%
    2. Secondary Outcome
    Title Relationship Between SPECT and CMR Results of Myocardial Perfusion Imaging
    Description Relationship between SPECT and CMR results of myocardial perfusion imaging for 1 Year
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    Coronary imaging pulse sequences were unable to be performed. All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.
    Arm/Group Title Healthy Patients
    Arm/Group Description Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
    Measure Participants 0
    3. Secondary Outcome
    Title Optimization of Coronary Imaging Using CMR
    Description Optimization of coronary imaging using CMR for 1 Year
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    Coronary imaging were unable to be performed. All efforts were taken to gather all possible data but none were obtained for this Outcome Measure.
    Arm/Group Title Healthy Patients
    Arm/Group Description Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
    Measure Participants 0

    Adverse Events

    Time Frame 3 Years
    Adverse Event Reporting Description Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects.
    Arm/Group Title Healthy Patients
    Arm/Group Description Twenty healthy subjects underwent CMR perfusion imaging during resting conditions, during regadenoson-induced hyperemia (0.4 mg), and after 15 min of recovery.
    All Cause Mortality
    Healthy Patients
    Affected / at Risk (%) # Events
    Total 0/20 (0%)
    Serious Adverse Events
    Healthy Patients
    Affected / at Risk (%) # Events
    Total 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    Healthy Patients
    Affected / at Risk (%) # Events
    Total 9/20 (45%)
    Cardiac disorders
    Palpitations 7/20 (35%) 7
    Chest pressure or heaviness 7/20 (35%) 7
    Flushing 5/20 (25%) 5
    Gastrointestinal disorders
    Dysgeusia immediately following aminophylline administration 2/20 (10%) 2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea or difficulty with breath 9/20 (45%) 9

    Limitations/Caveats

    This study was conducted in a small number of healthy volunteers. We could not assess whether a rest stress protocol as opposed to a stress-recovery protocol would mask the presence of ischemia due to contrast contamination of stress images. It is possible that postregadenoson recovery imaging either earlier or later would have demonstrated a lesser degree of residual hyperemia. It is unknown whether a relatively modest underestimation of perfusion reserve would have clinical significance.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Amit Patel
    Organization The University of Chicago
    Phone 773-702-9461
    Email apatel2@medicine.bsd.uchicago.edu
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00871260
    Other Study ID Numbers:
    • 16570B
    First Posted:
    Mar 30, 2009
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021