Pulmonary EmbolismREMATEVNCT04980924
Epidemiology and Clinical Course of Pulmonary Embolism During and After Hospitalisation
An observational study of Pulmonary Embolism, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This survey will allow to identify PE prognostic, but also long-term complications, i.e. recurrence rate, on-treatment bleedings, deep-vein thrombosis sequella, pulmonary hypertension rate, and chronic pulmonary disease rate without PH. This database should help us identify risk-factors for each event. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 547 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 1992to 31 Dec 1997
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All pulmonary embolisms hospitalised in our department
Who may be able to join
- All pulmonary embolisms hospitalised in Nice hospital.
- acceptation to enter in the cohorte survey
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Embolism Registry
This survey will allow to identify PE prognostic, but also long-term complications, i.e. recurrence rate, on-treatment bleedings, deep-vein thrombosis sequella, pulmonary hypertension rate, and chronic pulmonary disease rate without PH. This database should help us identify risk-factors for each event.
- Conditions
- Pulmonary Embolism
- Being tested
- no intervention
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Embolism without reccurence or complication | Pulmonary Embolism without reccurence or complication Receives: Other: no intervention | |
| Pulmonary Embolism with reccurence or complication | Pulmonary Embolism with reccurence or complication, in particular occurrence of pulmonary hypertension. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reccurence
number of patient with Documented symptomatic pulmonary embolism reccurence
Measured: 10 years
Secondary outcomes (2)
Pulmonary hypertension
number of patients with Confirmed pulmonary hypertension after pulmonary embolism
Measured: 10 years
Chronic pulmonary disease without hypertension
number of patients with dyspnea but without pulmonary hypertension, Documented non-reperfused pulmonary areas
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jan 1992
- Primary completion31 Dec 1997
- Study completion31 Dec 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980924
- Sponsor's protocol ID
- 21cardio01
- Acronym
- REMATEV
- Status last verified
- Mar 2025
- First submitted
- 21 Jul 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrari E, Fourrier E, Asarisi F, Heme N, Redjimi N, Berkane N, Labbaoui M, Breittmayer JP, Bun SS, Moceri P, Squara F. Is pulmonary embolism recurrence linked with the severity of the first event? A French retrospective cohort study. BMJ Open. 2021 Sep 29;11(9):e050910. doi: 10.1136/bmjopen-2021-050910.
PubMed 34588255
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism Registry
- ClinicalTrials.gov ID
- NCT04980924
- Acronym / sponsor ID
- REMATEV / 21cardio01
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 1992 (actual)
- Primary completion
- 31 Dec 1997 (actual)
- Study completion
- 31 Dec 1997 (actual)
- First posted
- 28 Jul 2021 (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.
This survey will allow to identify PE prognostic, but also long-term complications, i.e. recurrence rate, on-treatment bleedings, deep-vein thrombosis sequella, pulmonary hypertension rate, and chronic pulmonary disease rate without PH. This database should help us identify risk-factors for each event.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Embolism without reccurence or complication | – | Other: no interventionPulmonary Embolism without reccurence or complication |
| Pulmonary Embolism with reccurence or complication | – | Other: no interventionPulmonary Embolism with reccurence or complication, in particular occurrence of pulmonary hypertension. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All pulmonary embolisms hospitalised in our department
Key inclusion criteria (2 listed)
- All pulmonary embolisms hospitalised in Nice hospital.
- acceptation to enter in the cohorte survey
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| no interventionno intervention | Other | Pulmonary Embolism with reccurence or complication, Pulmonary Embolism without reccurence or complication |
Primary outcome
Reccurence
Time frame: 10 years
number of patient with Documented symptomatic pulmonary embolism reccurence
2 secondary outcomes
Pulmonary hypertension
Time frame: 10 years
Chronic pulmonary disease without hypertension
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 34588255Ferrari E, Fourrier E, Asarisi F, Heme N, Redjimi N, Berkane N, Labbaoui M, Breittmayer JP, Bun SS, Moceri P, Squara F. Is pulmonary embolism recurrence linked with the severity of the first event? A French retrospective cohort study. BMJ Open. 2021 Sep 29;11(9):e050910. doi: 10.1136/bmjopen-2021-050910.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Universitaire de Nice 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reccurence (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980924, which also lists 1 linked publication.
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 6 Mar 2025.