Prediction of Patient-specific Outcomes After Interventional neuroRadiology Procedures (PREDICTNRI)

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.

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 Overview

• Status: Recruiting
• Conditions: Stroke; Aneurysmal Disease

• Study Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

• Study Contact: Name: Jean-Christophe GENTRIC, PUPH; Phone Number: +33 209347479; Email: jean-christophe.gentric@chu-brest.fr
• Study Contact Backup: Name: Samuel GUIGO; Phone Number: +33 298347532; Email: samuel.guigo@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Samuel GUIGO; Phone Number: +33 298347532; Email: samuel.guigo@chu-brest.fr
    • Contact: Jean-Christophe GENTRIC, PUPH; Phone Number: +33 298347479; Email: jean-christophe.gentric@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Major patient carrying either a small or large, ruptured or unruptured aneurysm or a thrombectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Thrombectomy group; Major patients requiring management for endovascular thrombosis
Aneurysm group; Major patients requiring management for an intracranial aneurysm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evolution	Clinical evolution was followed by the relevant clinical signs	24 months
Neurological evolution	Neurological evolution was followed by the neurologicsigns	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: INTRADYS

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2021
• Primary Completion (ANTICIPATED): January 4, 2025
• Study Completion (ANTICIPATED): January 4, 2025

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (ACTUAL): August 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: aneurysm; thrombectomy
• Other Study ID Numbers: 29BRC20.0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending five years following the princeps publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No