Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients (MAXIME)

September 13, 2019 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

MeAsurement of uneXpected Acute Pulmonary embolIsM Among Not Anticoagulated Patients Older Than 75 Years Admitted With Syncope.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will be proposed to every patient that correspond to eligibility criteria. Will be included only those who are not opposed to the collection of their data.

The data collected will come from the routine care such as medical history, clinical datas, imaging data… The number of pulmonary imaging will be assessed before the diagnostic strategy proposed by Dr Prandoni and after the application of this strategy thanks to a questionnaire to physicians.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Var
      • La Seyne-sur-Mer, Var, France, 83500
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary embolism
data from routine care will be collected for patient eligible and willing to participate
Other: data collection
data from patient included will be collected during the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary embolism prevalence
Time Frame: 24 month
Prevalence rate of pulmonary embolism among patient hospitalized for syncope and diagnosed with ventilation/perfusion scan or CT scan.
24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the impact of the Prandoni's recommendations on the paraclinical evaluations
Time Frame: 24 month
Number of CT-scans that are made systematically since the Prandoni's recommendations are applied in the hospital
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Principal Investigator: Benoit Faucher, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2018

Primary Completion (Actual)

November 27, 2018

Study Completion (Actual)

November 27, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-CHITS-04
  • 2017-A01197-46 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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