Non-severe Pulmonary EmbolismInCaPENCT06598930
Evaluation of the Effectiveness of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone in Non-severe Pulmonary Embolism.
A study testing Routine follow-up and Intensive follow-up in people with Non-severe Pulmonary Embolism, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In France, venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep-vein thrombosis (DVT), is the 3rd leading cause of cardiovascular disease, leading to major public health problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-severe Pulmonary Embolism
- What is being tested?
- Routine follow-up and Intensive follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person who has given oral consent
- Person affiliated to the social security system
- Over 18 years of age
- Resident in the 21-52 region
- Emergency care at Dijon University Hospital or Langres University Hospital less than 24 hours after diagnosis of non-severe pulmonary embolism (spESI = 0)
- Symptomatic PE is confirmed if there is :
Show all 10Show fewer
- a high pre-test clinical probability and a high probability ventilation-perfusion (V/Q) lung scan according to the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) criteria
- a proximal DVT diagnosed by ultrasound in a patient with symptoms of PE;
- a positive CT pulmonary angiogram (PA) showing a central filling defect highlighted by contrast material or a complete occlusion in a segmental or more proximal pulmonary artery.
- No contraindication to anticoagulant treatment
Who cannot join
- Person not affiliated to or not benefiting from a social security scheme
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
- Pregnant women, women in labour or breastfeeding mothers
- An adult who is incapable or unable to give consent
- Minors
- Contraindication to anticoagulant treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Anne-Lise ANTEMI-RIBREUX, 0380669363 ext. +33, anne-lise.antemi@chu-dijon.fr
About this study
Official title: Evaluation of the Efficacy of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone, in Non-severe Pulmonary Embolism - Randomised Open Study At Dijon University Hospital and Langres University Hospital.
In France, venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep-vein thrombosis (DVT), is the 3rd leading cause of cardiovascular disease, leading to major public health problems. Despite current monitoring and treatment, the recurrence rate and the rate of haemorrhagic complications remain high, at 18.5% and 12% respectively in the year following the thrombotic event.
Patients with PE diagnosed in the emergency department are very often admitted to hospital.
Read more
However, according to international recommendations on the treatment of PE, outpatient management with early discharge could be envisaged but is rarely carried out in practice, particularly for non-severe PE (spESI = 0).
Current post-pulmonary embolism follow-up involves an early medical consultation with a specialist after discharge from hospital, with follow-up at 1, 3 and 6 months. The aim is to evaluate anticoagulant treatment (high-risk medication), investigate the causes of PE, monitor the patient and decide whether or not to continue anticoagulant treatment 6 months after diagnosis.
Patients diagnosed with non-severe PE can only be monitored as soon as they are discharged from hospital, thanks to an organised and specific care pathway involving healthcare professionals working in towns and cities as well as in hospitals.
In 2018, the French authorities created a new healthcare profession, the advanced practice nurse (APN). They are said to be one of the \'answers\' to making care pathways, including PE, even more relevant by improving the quality of patient care and strengthening the town-hospital link.
Thanks to their training and expertise, IPAs can carry out the following activities:
- Observation, collection and interpretation of data in the context of patient monitoring in his/her area of expertise;
- Prescribing, renewing prescriptions and carrying out technical procedures as part of patient follow-up in their area of expertise;
- Designing, implementing and evaluating preventive and therapeutic education measures.
Thus, by intervening at specific times throughout the course of a patient\'s diagnosis of a non-severe PE, the involvement of the IPA in the patient\'s follow-up, in addition to current recommendations, would make it possible to reduce the risk of haemorrhagic complications associated with the use of anticoagulants.
- Conditions
- Non-severe Pulmonary Embolism
- Being tested
- Routine follow-up, Intensive follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine follow-upOther
As recommended: a vascular doctor exclusively, face-to-face consultations.
Intensive follow-upOther
a vascular physician and an IPA, with alternating face-to-face and remote consultations.
| Study group | Role | What they receive |
|---|---|---|
| Intensive follow-up | Experimental | Not described Receives: Other: Intensive follow-up |
| Routine follow-up | Active comparator | Not described Receives: Other: Routine follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of minor and major bleeds
ISTH definition of haemorrhage
Measured: Through study completion, on average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-severe Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598930
- Sponsor's protocol ID
- ANTEMI-RIBREUX AOIparaM 2023
- Acronym
- InCaPE
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone, in Non-severe Pulmonary Embolism - Randomised Open Study At Dijon University Hospital and Langres University Hospital.
- ClinicalTrials.gov ID
- NCT06598930
- Acronym / sponsor ID
- InCaPE / ANTEMI-RIBREUX AOIparaM 2023
- Conditions
- Non-severe Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
In France, venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep-vein thrombosis (DVT), is the 3rd leading cause of cardiovascular disease, leading to major public health problems. Despite current monitoring and treatment, the recurrence rate and the rate of haemorrhagic complications remain high, at 18.5% and 12% respectively in the year following the thrombotic event.
Patients with PE diagnosed in the emergency department are very often admitted to hospital.
However, according to international recommendations on the treatment of PE, outpatient management with early discharge could be envisaged but is rarely carried out in practice, particularly for non-severe PE (spESI = 0).
Current post-pulmonary embolism follow-up involves an early medical consultation with a specialist after discharge from hospital, with follow-up at 1, 3 and 6 months. The aim is to evaluate anticoagulant treatment (high-risk medication), investigate the causes of PE, monitor the patient and decide whether or not to continue anticoagulant treatment 6 months after diagnosis.
Patients diagnosed with non-severe PE can only be monitored as soon as they are discharged from hospital, thanks to an organised and specific care pathway involving healthcare professionals working in towns and cities as well as in hospitals.
In 2018, the French authorities created a new healthcare profession, the advanced practice nurse (APN). They are said to be one of the \'answers\' to making care pathways, including PE, even more relevant by improving the quality of patient care and strengthening the town-hospital link.
Thanks to their training and expertise, IPAs can carry out the following activities:
- Observation, collection and interpretation of data in the context of patient monitoring in his/her area of expertise;
- Prescribing, renewing prescriptions and carrying out technical procedures as part of patient follow-up in their area of expertise;
- Designing, implementing and evaluating preventive and therapeutic education measures.
Thus, by intervening at specific times throughout the course of a patient\'s diagnosis of a non-severe PE, the involvement of the IPA in the patient\'s follow-up, in addition to current recommendations, would make it possible to reduce the risk of haemorrhagic complications associated with the use of anticoagulants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive follow-up | Experimental | Other: Intensive follow-up |
| Routine follow-up | Active comparator | Other: Routine follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Person who has given oral consent
- Person affiliated to the social security system
- Over 18 years of age
- Resident in the 21-52 region
- Emergency care at Dijon University Hospital or Langres University Hospital less than 24 hours after diagnosis of non-severe pulmonary embolism (spESI = 0)
Key exclusion criteria (7 listed)
- Person not affiliated to or not benefiting from a social security scheme
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
- Pregnant women, women in labour or breastfeeding mothers
- An adult who is incapable or unable to give consent
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 |
|---|---|---|
| Routine follow-upAs recommended: a vascular doctor exclusively, face-to-face consultations. | Other | Routine follow-up |
| Intensive follow-upa vascular physician and an IPA, with alternating face-to-face and remote consultations. | Other | Intensive follow-up |
Primary outcome
Proportion of minor and major bleeds
Time frame: Through study completion, on average of 7 months
ISTH definition of haemorrhage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine follow-up and Intensive follow-up in people with Non-severe Pulmonary Embolism, run by Centre Hospitalier Universitaire Dijon 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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Lise ANTEMI-RIBREUX (0380669363 ext. +33, anne-lise.antemi@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of minor and major bleeds (time frame: Through study completion, on average of 7 months). 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 18 Dec 2024.