NCT03276507

Brief 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 questionnaires. Follow up will continue for at least one year.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

September 7, 2017

Last Update Submit

November 8, 2017

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

  • Dyspnea etiology

    All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire

    3 months

Secondary Outcomes (1)

  • Quality of Life

    6 months

Interventions

Pulmonary function studiesDIAGNOSTIC_TEST
EchocardiogramDIAGNOSTIC_TEST
ElectrocardiogramDIAGNOSTIC_TEST
Chest radiographyDIAGNOSTIC_TEST
Blood testDIAGNOSTIC_TEST
Quality of life questionnaireBEHAVIORAL

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing evaluation for dyspnea in a specialized clinic (Pulmonary and/or Cardiology)

You may qualify if:

  • Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea.

You may not qualify if:

  • Patients with a known cause of dyspnea such as established cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Jimenez Díaz

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Dyspnea

Interventions

EchocardiographyElectrocardiographyDiagnostic ImagingHematologic Tests

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosisClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • German Peces-Barba, MD

    Fundación Jimenez Díaz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis M Seijo, MD

CONTACT

91 550 4800luis.seijo@fjd.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)