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Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03951779
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
12.9
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Exercise cardiac magnetic resonance imaging
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Jan 10, 2020
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects with unexplained but suspected cardiac dyspnea

Subjects with unexplained but suspected cardiac dyspnea who are being scheduled for right heart catheterization will undergo an exercise cardiac magnetic resonance imaging (eCMR).

Diagnostic Test: Exercise cardiac magnetic resonance imaging
Subjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging
Other Names:
  • eCMR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ejection Fraction [Baseline]

      Measured using exercise cardiac magnetic resonance imaging (eCMR) reported in percentages

    2. Stroke Volume [Baseline]

      Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in mL

    3. Longitudinal Strain Assessment [Baseline]

      Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in percentages

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Consecutive patients aged ≥18 years years with suspected cardiac dyspnea who are scheduled to undergo right heart catheterization as dictated by a comprehensive examination and echocardiography will be included for enrollment.
    Exclusion Criteria:

    • Age <18 years

    • Pregnancy

    • Mechanical ventilation

    • Acute or chronic renal failure (creatinine clearance <30 ml/min or requiring renal replacement therapy)

    • Inability to perform MRI (i.e. claustrophobia, severe obesity (>150 kg), device incompatible with MRI)

    • Inability to exercise

    • Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)

    • Prior heart or lung transplantation

    • Left ventricular systolic (ejection fraction <50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)

    • Significant left-sided valvular disease (≥moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Brian P Shapiro, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Brian Shapiro, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03951779
    Other Study ID Numbers:
    • 18-005354
    First Posted:
    May 15, 2019
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dyspnea

    Study Results

    No Results Posted as of Apr 7, 2022