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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03951779
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2019
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Brian Shapiro, Mayo Clinic

Study Description
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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
Shortness of Breath Cardiac; Dyspnea Device: Exercise cardiac magnetic resonance imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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 : December 14, 2018
Estimated Primary Completion Date : January 4, 2023
Estimated Study Completion Date : January 4, 2023

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Arms and Interventions
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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).
 Device: 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 Name: eCMR


Outcome Measures
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Primary Outcome Measures :
  1. Ejection Fraction [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMR) reported in percentages

  2. Stroke Volume [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in mL

  3. Longitudinal Strain Assessment [ Time Frame: Baseline ]
    Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in percentages


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951779


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Brian P Shapiro Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Brian Shapiro, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03951779    
Other Study ID Numbers: 18-005354
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory