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

May 24, 2024 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with cerebral infarction treated in the acute phase by thrombectomy

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational group
Other: Quality of life Questionnaire
Quality of life questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: At 3 months
At 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: At 3 months
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)
Time Frame: At 12 months
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)
Time Frame: At 12 months
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)
Time Frame: At 3 months
At 3 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to material used for MT
Time Frame: At 3 months
At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to material used for MT
Time Frame: At 12 months
At 12 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the type of anesthesia (conscious sedation / general anesthesia)
Time Frame: At 12 months
At 12 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the type of anesthesia (conscious sedation / general anesthesia)
Time Frame: At 3 months
At 3 months
Evaluate functional recovery at 3 months (mRS ≤ 2) according to the impact of metrics from the radiological assessment in patient care
Time Frame: At 3 months
At 3 months
Evaluate functional recovery at 12 months (mRS ≤ 2) according to the impact of metrics from the radiological assessment in patient care
Time Frame: At 12 months
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0393

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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