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

NCT ID: NCT03951779

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2020-01-10

Brief Summary

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

Detailed Description

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Conditions

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Shortness of Breath Cardiac; Dyspnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Exercise cardiac magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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eCMR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Brian Shapiro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian P Shapiro

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-005354

Identifier Type: -

Identifier Source: org_study_id

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