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

Primary Purpose

Shortness of Breath, Cardiac; Dyspnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise cardiac magnetic resonance imaging

About this trial

This is an interventional diagnostic trial for Shortness of Breath

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects with unexplained but suspected cardiac dyspnea

Arm 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).

Outcomes

Primary Outcome Measures

Ejection Fraction

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

Stroke Volume

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

Longitudinal Strain Assessment

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03951779

First Posted

May 14, 2019

Last Updated

March 29, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03951779

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 14, 2018 (Actual)

Primary Completion Date

January 10, 2020 (Actual)

Study Completion Date

January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shortness of Breath, Cardiac; Dyspnea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects with unexplained but suspected cardiac dyspnea

Arm Type

Experimental

Arm 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).

Intervention Type

Diagnostic Test

Intervention Name(s)

Exercise cardiac magnetic resonance imaging

Other Intervention Name(s)

eCMR

Intervention Description

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

Primary Outcome Measure Information:

Title

Ejection Fraction

Description

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

Time Frame

Baseline

Title

Stroke Volume

Description

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

Time Frame

Baseline

Title

Longitudinal Strain Assessment

Description

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

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian P Shapiro

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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