Shortness of BreathNCT03951779
Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
A study testing Exercise cardiac magnetic resonance imaging in people with Shortness of Breath and Cardiac; Dyspnea, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shortness of Breath, Cardiac; Dyspnea
- What is being tested?
- Exercise cardiac magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2018to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exercise cardiac magnetic resonance imaging
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise cardiac magnetic resonance imagingDiagnostic test
Also called eCMR
Subjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Exercise cardiac magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection Fraction
Measured using exercise cardiac magnetic resonance imaging (eCMR) reported in percentages
Measured: Baseline
Stroke Volume
Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in mL
Measured: Baseline
Longitudinal Strain Assessment
Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in percentages
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start14 Dec 2018
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shortness of BreathStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Shapiro, Mayo Clinic
- Investigators
- Brian P Shapiro, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951779
- Sponsor's protocol ID
- 18-005354
- Status last verified
- Mar 2022
- First submitted
- 14 May 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.
- ClinicalTrials.gov ID
- NCT03951779
- Acronym / sponsor ID
- 18-005354
- Conditions
- Shortness of Breath, Cardiac; Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with unexplained but suspected cardiac dyspnea | Experimental | Diagnostic Test: Exercise cardiac magnetic resonance imagingSubjects with unexplained but suspected cardiac dyspnea who are being scheduled for right heart catheterization will undergo an exercise cardiac magnetic resonance imaging (eCMR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise cardiac magnetic resonance imagingAlso: eCMRSubjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging | Diagnostic test | Subjects with unexplained but suspected cardiac dyspnea |
Primary outcome
Ejection Fraction
Time frame: Baseline
Measured using exercise cardiac magnetic resonance imaging (eCMR) reported in percentages
Stroke Volume
Time frame: Baseline
Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in mL
Longitudinal Strain Assessment
Time frame: Baseline
Measured using exercise cardiac magnetic resonance imaging (eCMG) reported in percentages
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P Shapiro principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise cardiac magnetic resonance imaging in people with Shortness of Breath and Cardiac; Dyspnea, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ejection Fraction (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.