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

Acute Ischemic Stroke Clinical Trial

— EPIC  

Official title:

Evaluation of Favorable Functional Recovery Predictors at 3 Months of Patients With Acute Ischemic Stroke Treated by Mechanical Thrombectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916782
• Other study ID #: RECHMPL19_0393
• Status: Recruiting
• Start date: April 28, 2022
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Cyril Dargazanli
• Phone: 04.67.33.75.32
• Email: c-dargazanli[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The management of cerebral infarction (CI) is a real public health issue. There are 120,000 hospitalizations of CI patients per year in France. It is the leading cause of acquired disability and the second leading cause of dementia. Since 2015, the scientific community has demonstrated the benefits of mechanical thrombectomy (MT) in the treatment of patients with CI. The French National Authority for Health (HAS) recommends MT either in combination with intravenous (IV) thrombolysis, or alone, after failure of IV thrombolysis or in case of contraindication to IV thrombolysis, within 6 hours of the onset of symptoms.

Based on previous studies, the HAS has extended its recommendations for the treatment of patients (with occlusion of large vessels of the anterior cerebral circulation) whose onset of symptoms or last seen asymptomatic is between 6 and 16 hours, and may even extend up to 24 hours depending on strict inclusion criteria.

These previous clinical trials have shown the remarkable efficacy of MT in CI patients under the age of 80. There are no clear recommendations for MT in patients over 80 years of age, and further research is needed to improve the safety of MT.

Further research is needed to improve patient selection in the elderly. Today, predictive factors impacting on functional recovery such as age, blood glucose, and NIHSS neurological severity score have been evaluated. However, no association between these factors during the course of treatment has been established to determine the clinical and radiological characteristics that define the standard profile of "good responders" to MT.

The cohort is a continuation of the data previously collected in a database of the Commission Nationale de l'Informatique et des Libertés (CNIL). This database reports a complete follow-up (clinical, imaging and MT procedure data) of patients, from admission to 3 months after their hospitalisation. Some results have already been published.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Quality of life Questionnaire
Quality of life questionnaire

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate functional recovery at 3 months (mRS = 2) according to material used for MT		At 3 months
Secondary	Evaluate functional recovery at 12 months (mRS = 2) according to material used for MT		At 12 months
Secondary	Evaluate functional recovery at 12 months (mRS = 2) according to the type of anesthesia (conscious sedation / general anesthesia)		At 12 months
Secondary	Evaluate functional recovery at 3 months (mRS = 2) according to the type of anesthesia (conscious sedation / general anesthesia)		At 3 months
Secondary	Evaluate functional recovery at 3 months (mRS = 2) according to the impact of metrics from the radiological assessment in patient care		At 3 months
Secondary	Evaluate functional recovery at 12 months (mRS = 2) according to the impact of metrics from the radiological assessment in patient care		At 12 months