Aneurysmal DiseasePREDICTNRINCT04504695
Prediction of Patient-specific Outcomes After Interventional neuroRadiology Procedures
An observational study of Aneurysmal Disease and Stroke, run by University Hospital, Brest at 1 site in France.
Trial summary
Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Disease, Stroke
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2021to 4 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy
Who may be able to join
- Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy, with in both cases, a treatment procedure carried out in the interventional neuroradiology department of the Brest CHRU.
Who cannot join
- Age < 18 years old
- Incapacitated patients of full age (under guardianship or curatorship)
- Refusal to participate
- Follow-up impossible
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Jean-Christophe GENTRIC, PUPH, 298347479 ext. +33, jean-christophe.gentric@chu-brest.fr
Samuel GUIGO, 298347532 ext. +33, samuel.guigo@chu-brest.fr
About this study
Official title: Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures
Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency.
An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain. It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There will then be a neurological deficit (paralysis) more or less important corresponding to the affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a part of the body (upper or lower limb) and sometimes is associated with facial paralysis and/or language disorders.
Read more
A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also occur later in life due to illness, head injury, oral contraceptives or certain lifestyle habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress or strenuous exercise can serve as a trigger.
Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using imaging to perform the medical procedure and thereby limit openings and their associated risks. This specialty has a growing place in modern medicine.
In order to improve the quality of care, patient safety and functional outcomes, it is necessary to keep patient information. A database storing patient data from the NRI department will make it possible to track patients since their arrival at the Brest University Hospital. Thanks to this structured database, clinical studies will be facilitated, making it possible to advance knowledge of the pathology and its treatments.
From the bibliographical research, we can conclude as to the current state of the facts: there is currently no method for predicting the functional results of the interventional neuroradiologist's patient based on automated learning.
A strategy based on an innovation programme is therefore being implemented over several years, the first stage of which is the retrospective data study which was approved by the ethics committee on 12/09/2019 and the second stage is the prospective data study.
This innovation program requires the most complete and homogeneous data possible.
- Conditions
- Aneurysmal Disease, Stroke
- Keywords
- thrombectomy, aneurysm
- Medical subject headings
- Stroke, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy group | Major patients requiring management for endovascular thrombosis | |
| Aneurysm group | Major patients requiring management for an intracranial aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive factors
Number of predictive factors (pre- and intra-operative data) for the angiographic success of the procedure (intracranial aneurysm or thrombectomy).
Measured: 24 months
Secondary outcomes (2)
Clinical evolution
Clinical evolution was followed by the relevant clinical signs
Measured: 24 months
Neurological evolution
Neurological evolution was followed by the neurologicsigns
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start4 Jan 2021
- Primary completion4 Jan 2025 (estimated)
- Study completion4 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- INTRADYS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504695
- Sponsor's protocol ID
- 29BRC20.0032
- Acronym
- PREDICTNRI
- Status last verified
- Jan 2021
- First submitted
- 3 Aug 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures
- ClinicalTrials.gov ID
- NCT04504695
- Acronym / sponsor ID
- PREDICTNRI / 29BRC20.0032
- Conditions
- Aneurysmal Disease, Stroke
- Keywords
- thrombectomy, aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- INTRADYS
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Jan 2025 (estimated)
- Study completion
- 4 Jan 2025 (estimated)
- First posted
- 7 Aug 2020 (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.
Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency.
An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain. It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There will then be a neurological deficit (paralysis) more or less important corresponding to the affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a part of the body (upper or lower limb) and sometimes is associated with facial paralysis and/or language disorders.
A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also occur later in life due to illness, head injury, oral contraceptives or certain lifestyle habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress or strenuous exercise can serve as a trigger.
Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using imaging to perform the medical procedure and thereby limit openings and their associated risks. This specialty has a growing place in modern medicine.
In order to improve the quality of care, patient safety and functional outcomes, it is necessary to keep patient information. A database storing patient data from the NRI department will make it possible to track patients since their arrival at the Brest University Hospital. Thanks to this structured database, clinical studies will be facilitated, making it possible to advance knowledge of the pathology and its treatments.
From the bibliographical research, we can conclude as to the current state of the facts: there is currently no method for predicting the functional results of the interventional neuroradiologist's patient based on automated learning.
A strategy based on an innovation programme is therefore being implemented over several years, the first stage of which is the retrospective data study which was approved by the ethics committee on 12/09/2019 and the second stage is the prospective data study.
This innovation program requires the most complete and homogeneous data possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy group | – | –Major patients requiring management for endovascular thrombosis |
| Aneurysm group | – | –Major patients requiring management for an intracranial aneurysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy
Key inclusion criteria (1 listed)
- Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy, with in both cases, a treatment procedure carried out in the interventional neuroradiology department of the Brest CHRU.
Key exclusion criteria (4 listed)
- Age < 18 years old
- Incapacitated patients of full age (under guardianship or curatorship)
- Refusal to participate
- Follow-up impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of predictive factors
Time frame: 24 months
Number of predictive factors (pre- and intra-operative data) for the angiographic success of the procedure (intracranial aneurysm or thrombectomy).
2 secondary outcomes
Clinical evolution
Time frame: 24 months
Neurological evolution
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
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 Aneurysmal Disease and Stroke, run by University Hospital, Brest 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe GENTRIC, PUPH (209347479 ext. +33, jean-christophe.gentric@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive factors (time frame: 24 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 27 Jan 2021.