Pulmonary EmbolismMAXIMENCT03525535
Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients
An observational study of Pulmonary Embolism, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- data collection
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2018to 27 Nov 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: male or female over 75 years old without anticoagulated treatment hospitalized for syncope symptoms.
Who may be able to join
- 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
Who cannot join
- history of syncope
- other loss of consciousness (epilepsy, stroke, head trauma)
- anticoagulated treatment
- patient's objection
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
La Seyne-sur-Mer, Var, 83500
About this study
Official title: 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
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- data collection
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data from patient included will be collected during the study
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary embolism | data from routine care will be collected for patient eligible and willing to participate Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary embolism prevalence
Prevalence rate of pulmonary embolism among patient hospitalized for syncope and diagnosed with ventilation/perfusion scan or CT scan.
Measured: 24 month
Secondary outcomes (1)
Assess the impact of the Prandoni's recommendations on the paraclinical evaluations
Number of CT-scans that are made systematically since the Prandoni's recommendations are applied in the hospital
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start14 Jun 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Why it stopped: Principal investigator departure without possible replacement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Faucher, MD, Principal investigator, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525535
- Sponsor's protocol ID
- 2017-CHITS-04
- Other IDs
- 2017-A01197-46
- Acronym
- MAXIME
- Status last verified
- Sep 2019
- First submitted
- 3 May 2018
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeAsurement of uneXpected Acute Pulmonary embolIsM Among Not Anticoagulated Patients Older Than 75 Years Admitted With Syncope.
- ClinicalTrials.gov ID
- NCT03525535
- Acronym / sponsor ID
- MAXIME / 2017-CHITS-04
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal investigator departure without possible replacement
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 15 May 2018 (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 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary embolism | – | Other: data collectiondata from routine care will be collected for patient eligible and willing to participate |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- male or female over 75 years old without anticoagulated treatment hospitalized for syncope symptoms.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- history of syncope
- other loss of consciousness (epilepsy, stroke, head trauma)
- anticoagulated treatment
- patient's objection
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 |
|---|---|---|
| data collectiondata from patient included will be collected during the study | Other | Pulmonary embolism |
Primary outcome
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.
1 secondary outcome
Assess the impact of the Prandoni's recommendations on the paraclinical evaluations
Time frame: 24 month
Results and safety
The study was stopped early (reason given: Principal investigator departure without possible replacement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No. no plan to share IPD
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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.
Benoit Faucher, MD principal investigator
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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 Pulmonary Embolism, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Sep 2019. 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 France. 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?
The study was stopped early (reason given: Principal investigator departure without possible replacement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary embolism prevalence (time frame: 24 month). 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 16 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.