DyspneaMUSENCT03276507
Multisystem Shortness of Breath Evaluation Study
An observational study of Dyspnea, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The MUSE study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dyspnea
- What is being tested?
- Pulmonary function studies, Echocardiogram and Electrocardiogram
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2016to 1 Jun 2018
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing evaluation for dyspnea in a specialized clinic (Pulmonary and/or Cardiology)
Who may be able to join
- Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea.
Who cannot join
- Patients with a known cause of dyspnea such as established cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundación Jimenez Díaz
Madrid, 28040
Luis M Seijo, MD, 31 550 4800 ext. 2418, luis.seijo@fjd.es
About this study
The MUSE study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related questionnaires. Follow up will continue for at least one year.
- Conditions
- Dyspnea
- Being tested
- Pulmonary function studies, Echocardiogram, Electrocardiogram, Chest radiography, Blood test
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function studiesDiagnostic test
EchocardiogramDiagnostic test
ElectrocardiogramDiagnostic test
Chest radiographyDiagnostic test
Blood testDiagnostic test
Quality of life questionnaireBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea etiology
All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire
Measured: 3 months
Secondary outcomes (1)
Quality of Life
Several questionnaires will be used including the M3 questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Nov 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUIS SEIJO MACEIRAS, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Investigators
- German Peces-Barba, MD, Principal investigator, Fundación Jimenez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276507
- Sponsor's protocol ID
- EO 113/2016_FJD
- Acronym
- MUSE
- Status last verified
- Nov 2017
- First submitted
- 7 Sep 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisystem Shortness of Breath Evaluation Study
- ClinicalTrials.gov ID
- NCT03276507
- Acronym / sponsor ID
- MUSE / EO 113/2016_FJD
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 8 Sep 2017 (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.
The MUSE study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related questionnaires. Follow up will continue for at least one year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing evaluation for dyspnea in a specialized clinic (Pulmonary and/or Cardiology)
Key inclusion criteria (1 listed)
- Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea.
Key exclusion criteria (1 listed)
- Patients with a known cause of dyspnea such as established cardiopulmonary disease
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 |
|---|---|---|
| Pulmonary function studies | Diagnostic test | – |
| Echocardiogram | Diagnostic test | – |
| Electrocardiogram | Diagnostic test | – |
| Chest radiography | Diagnostic test | – |
| Blood test | Diagnostic test | – |
| Quality of life questionnaire | Behavioural | – |
Primary outcome
Dyspnea etiology
Time frame: 3 months
All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire
1 secondary outcome
Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- 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.
German Peces-Barba, MD principal investigator
Fundación Jimenez Díaz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2017. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis M Seijo, MD (91 550 4800 ext. 2418, luis.seijo@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea etiology (time frame: 3 months). 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 9 Nov 2017.