Prediction of Patient-specific Outcomes After Interventional neuroRadiology Procedures

Stroke Clinical Trial

— PREDICTNRI  

Official title:

Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04504695
• Other study ID #: 29BRC20.0032
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: January 4, 2025

Study information

• Verified date: January 2021
• Source: University Hospital, Brest
• Contact: Jean-Christophe GENTRIC, PUPH
• Phone: 209347479
• Email: jean-christophe.gentric[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: January 4, 2025
• Est. primary completion date: January 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Age < 18 years old

• Incapacitated patients of full age (under guardianship or curatorship)

• Refusal to participate

• Follow-up impossible

Related Conditions & MeSH terms

• Aneurysmal Disease
• Stroke

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	INTRADYS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of predictive factors	Number of predictive factors (pre- and intra-operative data) for the angiographic success of the procedure (intracranial aneurysm or thrombectomy).	24 months
Secondary	Clinical evolution	Clinical evolution was followed by the relevant clinical signs	24 months
Secondary	Neurological evolution	Neurological evolution was followed by the neurologicsigns	24 months