Evaluation of Functional Recovery of Patients With Acute Ischemic Stroke Treated by Thrombectomy

NCT04916782 | Recruiting

• 1 other identifier: RECHMPL19_0393
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

The management of cerebral infarctions (CI) is a real public health issue. The French National Authority for Health recommends Mechanical Thrombectomy (MT) either in combination with Intravenous Thrombolysis (IVT), or alone, after failure of IVT or in case of contraindication to IVT, within 6 hours of the onset of symptoms. The objective is to determine the factors predicting good functional recovery at 3 months in order to establish the typical profile of the "good responder" patient to MT and to evaluate functional recovery at 3 and 12 months (mRS ≤ 2) according to the modality of MT (depending on whether it is performed during the day or at night), the age of the patients, the equipment used for MT, the type of anaesthesia, as well as the impact of the metrics from the radiological evaluation in the patient's management. patient management.

Conditions

Acute Ischemic Stroke

Keywords

stroke; outcome; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Determine the predictive factors of good functional recovery (modified Rankin Score (mRS) ≤ 2) at 3 months in order to establish the typical profile of the patient "good responder" to Mechanical Thrombectomy (MT)

  At 3 months

Secondary Outcomes (10)

• Evaluate functional recovery at 3 months (mRS ≤ 2) according to the modality of MT (depending on whether it is carried out during the day or at night)

  At 3 months

• Evaluate functional recovery at 12 months (mRS ≤ 2) according to the modality of MT (depending on whether it is carried out during the day or at night)

  At 12 months

• Evaluate functional recovery at 12 months (mRS ≤ 2) according to the age of the patients, specifically for the very elderly (> 80 years old)

  At 12 months

• Evaluate functional recovery at 3 months (mRS ≤ 2) according to the age of the patients, specifically for the very elderly (> 80 years old)

  At 3 months

• Evaluate functional recovery at 3 months (mRS ≤ 2) according to material used for MT

  At 3 months

Study Arms (1)

Observational group

Other: Quality of life Questionnaire

Interventions

Quality of life Questionnaire OTHER

Quality of life questionnaire

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with cerebral infarction treated in the acute phase by thrombectomy

You may qualify if:

• Age ≥ 18 years
• Indication for treatment with Mechanical Thrombectomy
• Imaging on admission (Scanner and/or Magnetic Resonance Imaging (MRI)) showing occlusion of a large intracranial artery intracranial artery (anterior, middle, posterior cerebral artery, basilar artery, vertebral vertebral artery)
• Health insurance coverage
• Obtaining the patient's consent

You may not qualify if:

• Patient with a serious intercurrent pathology impacting the vital prognosis in the short term and making it impossible to follow up at 3 months.
• Patients for whom follow-up will be impossible (foreign tourists)
• Patients of legal age (under guardianship, under curatorship, deprived of liberty)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Cyril Dargazanli

CONTACT

04.67.33.75.32; c-dargazanli@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: April 28, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

FR (1)