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Completed

NCT Number: NCT03951779

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

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

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Key information

Conditions

Shortness of Breath Cardiac; Dyspnea Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise cardiac magnetic resonance imaging

Diagnostic Test

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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