Multisystem Shortness of Breath Evaluation Study | NCT03276507

Studies
Multisystem Shortness of Breath Evaluation Study

NCT03276507

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status

Unknown status

Last Update Posted

Nov 9, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Dyspnea

Interventions

Pulmonary function studies
Echocardiogram
Electrocardiogram
Chest radiography
Blood test
Quality of life questionnaire

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016Actual

Primary Completion Date

Dec 1, 2017Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Sep 7, 2017

First Submission Date that Met QC Criteria

Sep 7, 2017

First Posted Date

Sep 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2017

Last Update Posted Date

Nov 9, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LUIS SEIJO MACEIRAS, Attending Physician, Instituto de Investigación Sanitaria de la Fundación Jiménez DíazPrincipal Investigator

Lead Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez DíazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary function studies	Diagnostic Test
Echocardiogram	Diagnostic Test
Electrocardiogram	Diagnostic Test
Chest radiography	Diagnostic Test
Blood test	Diagnostic Test
Quality of life questionnaire	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dyspnea etiology	All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire	3 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life	Several questionnaires will be used including the M3 questionnaire	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luis M Seijo, MD	Contact	91 550 4800	2418	luis.seijo@fjd.es

Overall Officials

Name	Affiliation	Role
German Peces-Barba, MD	Fundación Jimenez Díaz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Jimenez Díaz	Recruiting	Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004452	Echocardiography
D004562	Electrocardiography
D003952	Diagnostic Imaging
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D057791	Cardiac Imaging Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D014463	Ultrasonography

Browse Leaves

Not provided

Browse Branches

Not provided