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

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

Sponsors

Lead sponsor: Mayo Clinic

Source Mayo Clinic
Brief Summary

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

Overall Status Enrolling by invitation
Start Date December 14, 2018
Completion Date January 4, 2021
Primary Completion Date January 4, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ejection Fraction Baseline
Stroke Volume Baseline
Longitudinal Strain Assessment Baseline
Enrollment 35
Condition
Intervention

Intervention type: Device

Intervention name: Exercise cardiac magnetic resonance imaging

Description: Subjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging

Arm group label: Subjects with unexplained but suspected cardiac dyspnea

Other name: eCMR

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Brian P Shapiro Principal Investigator Mayo Clinic
Location
facility Mayo Clinic in Florida
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mayo Clinic

Investigator full name: Brian Shapiro

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Subjects with unexplained but suspected cardiac dyspnea

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov