IMMunological ResPonse Assessment AfteR Acute ISchemic Stroke Treated with Endovascular Therapy (IMPRESS)

Recruiting

• Conditions: Ischemic Stroke; Thrombectomy

• Registration Number: NCT04663399
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 months of AIC treatment.

Detailed Description

Stroke is the second leading cause of death worldwide, the leading cause of acquired disability and the second leading cause of dementia. Ischaemic strokes account for 80% of strokes, 40% of which are caused by occlusion of a large-calibre artery in the polygon of Willis. In 2020, the treatment focuses on recanalisation, as quickly as possible. This is achieved medically by intravenous thrombolysis (IVT) and, since 2015, by mechanical thrombectomy (MT) in cases of proximal anterior artery occlusion. Thrombectomy has revolutionised the management of AIC, as it results in over 90% recanalisation at the end of treatment. However, more than half of patients managed between 3 and 6 hours, and recanalised with TM, remain dependent at 3 months.

In recent years, numerous studies (mainly preclinical) have highlighted the impact of the systemic and cerebral inflammatory reaction following AIC. Interestingly, this immuno-inflammatory reaction seems to follow a precise chronology and involves various immune players. Several preclinical studies in rodents have shown that this immunoinflammatory response appears to be strongly associated with prognosis (final stroke volume, disability and post-stroke dementia).

The absence of reliable biomarkers in humans to better describe and assess the chronology of the immuno-inflammatory profile after stroke appears to be a fundamental limitation to the introduction of innovative treatments. These biomarkers would make it possible to select and accurately assess the time required to introduce treatments such as immunomodulatory therapies (Natalizumab, Fingolimod, Copaxone, cell therapy, etc.). New studies seem necessary to identify peripheral biomarkers of the immuno-inflammatory state (cytokines, precise cell typing), and of thrombo-inflammation (NETose markers, neutrophil markers) and their consequences on disability after an ACI.

The aim of the IMPRESS study is therefore to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24 +/-12 hours of the management of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis 3 months after the AIC has been managed.

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Study Start: 2023-02-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2028-05-23
• Study Completion: 2028-05-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patient with an acute ischemic stroke for which treatment with mechanical thrombectomy is indicated, whether or not thrombectomy is performed,
• Having received informed information about the study and having signed a consent to participate in the study (if this is not possible: information and consent of the trusted support person or family member if present; emergency inclusion if absent);
• Affiliated or beneficiary of a social security scheme or equivalent.

Non inclusion Criteria:

• Pregnant or breast-feeding women
• Patient benefiting from a legal protection measure

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie.	21 months	Blood plasma collected from patients at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment will be used to discover and validate panels of inflammatory biomarkers that are predictive of therapeutic response. The biomarkers will be measured using a multiplex preconfigured panels for inflammatory biomarkers.

Trial Locations

Locations (1)

Hôpital Fondation Adolphe de Rothschild; 🇫🇷 Paris, France