NCT03525535

Brief Summary

The purpose of this study is to evaluate the prevalence rate of pulmonary embolism among not anticoagulated patient older than 75 years old admitted with syncope and hospitalised in the Toulon Hospital

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 3, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

May 3, 2018

Last Update Submit

September 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulmonary embolism prevalence

    Prevalence rate of pulmonary embolism among patient hospitalized for syncope and diagnosed with ventilation/perfusion scan or CT scan.

    24 month

Secondary Outcomes (1)

  • Assess the impact of the Prandoni's recommendations on the paraclinical evaluations

    24 month

Study Arms (1)

Pulmonary embolism

data from routine care will be collected for patient eligible and willing to participate

Other: data collection

Interventions

data from patient included will be collected during the study

Pulmonary embolism

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male or female over 75 years old without anticoagulated treatment hospitalized for syncope symptoms.

You may qualify if:

  • Male or Female over 75 years-old
  • Emergency consult resulting on an hospitalization in the geriatric service or in the internal medicine service
  • Hospitalised in the Centre Hospitalier Intercommunal de Toulon for syncope, presenting these symptoms:
  • Loss of consciousness with quick return to normal (less than one minute)
  • Spontaneous resolution

You may not qualify if:

  • history of syncope
  • other loss of consciousness (epilepsy, stroke, head trauma)
  • anticoagulated treatment
  • patient's objection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

La Seyne-sur-Mer, Var, 83500, France

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Benoit Faucher, MD

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 15, 2018

Study Start

June 14, 2018

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

no plan to share IPD

Locations