Ischemic StrokeNERVALNCT06026696
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Neurovascular diseases can cause ischaemic or haemorrhagic strokes. While the most common, such as atherosclerosis are widely studied, others are less well known, such as arterial dissections or cerebral angiopathies. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- follow-up
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2038
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated for acute cerebrovascular disease
Who may be able to join
- Adult patients ≥18 years
- Patients admitted to the Neurovascular Intensive Care Unit with acute cerebrovascular disease OR Patients managed for acute cerebrovascular pathology with or without stroke by the Lariboisière neurology team.
- No opposition from the patient to the research and for patients under guardianship or guardianship or lack of capacity to object (severe impairment of cognitive functions, dementia, etc.), no opposition from the legal representative.
Who cannot join
- Patient refusing to take part in the study or refusal by the legal representative in the case of patients under guardianship or curatorship
- Patient suffering from a rare neurovascular disease and being followed at the "Centre de référence des maladies vasculaires rares du cerveau et de l'oeil" (CERVCO)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière
Neurovascular diseases can cause ischaemic or haemorrhagic strokes. While the most common, such as atherosclerosis are widely studied, others are less well known, such as arterial dissections or cerebral angiopathies. What's more, most studies are limited to a few years' follow-up and the longer-term evolution of patients is less well assessed. Patient follow-up data available in routine practice and specific enrollment through the headache emergencies of the Lariboisière neurovascular intensive care unit (USINV) could provide a particularly rich resource.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- follow-up
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-upOther
Long term follow-up
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for acute cerebrovascular pathology cerebrovascular disease | Not described Receives: Other: follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a vascular event
Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.
Measured: Up to 5 years
Secondary outcomes (20)
Incidence of a vascular event
Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.
Measured: Up to 10 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 3 months
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 1 year
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 2 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 3 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 4 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 5 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 6 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 7 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 8 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 9 years
Modified Rankin score
The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
Measured: At 10 years
Occurrence of intercurrent pathologies requiring specific treatment
Pathologies are defined as : anxiety-depressive disorder, dementia, comititude, neoplasia, venous thromboembolism, haemorrhage, systemic disease, respiratory insufficiency
Measured: Up to 10 years
Obstetrical prognosis
Incidence of pregnancies, complications, delivery methods
Measured: Up to 10 years
Incidence of death
Age and causes of death
Measured: Up to 10 years
Prevalence of vascular risk factors
Medical history, LDL (Low Density Lipoprotein), Tobacco, Arterial pressure, HbA1C (glycated hemoglobin)
Measured: Up to 10 years
Number of associated treatments
Description of the types of treatment used
Measured: Up to 10 years
Number of adverse events
Evaluation of treatment tolerance
Measured: Up to 10 years
Treatment adherence
Measured: Up to 10 years
Incidence of headaches
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2033 (estimated)
- Study completionSep 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026696
- Sponsor's protocol ID
- APHP221076
- Acronym
- NERVAL
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière
- ClinicalTrials.gov ID
- NCT06026696
- Acronym / sponsor ID
- NERVAL / APHP221076
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Sep 2038 (estimated)
- First posted
- 7 Sep 2023 (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.
Neurovascular diseases can cause ischaemic or haemorrhagic strokes. While the most common, such as atherosclerosis are widely studied, others are less well known, such as arterial dissections or cerebral angiopathies. What's more, most studies are limited to a few years' follow-up and the longer-term evolution of patients is less well assessed. Patient follow-up data available in routine practice and specific enrollment through the headache emergencies of the Lariboisière neurovascular intensive care unit (USINV) could provide a particularly rich resource.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for acute cerebrovascular pathology cerebrovascular disease | – | Other: follow-up |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated for acute cerebrovascular disease
Key inclusion criteria (3 listed)
- Adult patients ≥18 years
- Patients admitted to the Neurovascular Intensive Care Unit with acute cerebrovascular disease OR Patients managed for acute cerebrovascular pathology with or without stroke by the Lariboisière neurology team.
- No opposition from the patient to the research and for patients under guardianship or guardianship or lack of capacity to object (severe impairment of cognitive functions, dementia, etc.), no opposition from the legal representative.
Key exclusion criteria (2 listed)
- Patient refusing to take part in the study or refusal by the legal representative in the case of patients under guardianship or curatorship
- Patient suffering from a rare neurovascular disease and being followed at the "Centre de référence des maladies vasculaires rares du cerveau et de l'oeil" (CERVCO)
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 |
|---|---|---|
| follow-upLong term follow-up | Other | Patients treated for acute cerebrovascular pathology cerebrovascular disease |
Primary outcome
Incidence of a vascular event
Time frame: Up to 5 years
Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.
20 secondary outcomes
Incidence of a vascular event
Time frame: Up to 10 years
Modified Rankin score
Time frame: At 3 months
Modified Rankin score
Time frame: At 1 year
Modified Rankin score
Time frame: At 2 years
Modified Rankin score
Time frame: At 3 years
Modified Rankin score
Time frame: At 4 years
Modified Rankin score
Time frame: At 5 years
Modified Rankin score
Time frame: At 6 years
Modified Rankin score
Time frame: At 7 years
Modified Rankin score
Time frame: At 8 years
Modified Rankin score
Time frame: At 9 years
Modified Rankin score
Time frame: At 10 years
Occurrence of intercurrent pathologies requiring specific treatment
Time frame: Up to 10 years
Obstetrical prognosis
Time frame: Up to 10 years
Incidence of death
Time frame: Up to 10 years
Prevalence of vascular risk factors
Time frame: Up to 10 years
Number of associated treatments
Time frame: Up to 10 years
Number of adverse events
Time frame: Up to 10 years
Treatment adherence
Time frame: Up to 10 years
Incidence of headaches
Time frame: Up to 10 years
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 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Peggy Reiner, Dr (+33149956525, peggy.reiner@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a vascular event (time frame: Up to 5 years). 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 7 Sep 2023.