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

NCT03951779 | Completed

• 1 other identifier: 18-005354
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shortness of Breath; Cardiac; Dyspnea

Outcome Measures

Primary Outcomes (3)

• Ejection Fraction

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

  Baseline

• Stroke Volume

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

  Baseline

• Longitudinal Strain Assessment

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

  Baseline

Study Arms (1)

Subjects with unexplained but suspected cardiac dyspnea

EXPERIMENTAL

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

Interventions

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

Also known as: eCMR

Subjects with unexplained but suspected cardiac dyspnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian P Shapiro

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: December 14, 2018
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)