Trials / Recruiting
RecruitingNCT04663399
IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy (IMPRESS)
IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,200 (estimated)
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 and 12 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 and 12 months after the AIC has been managed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Prospective patient | The immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment. |
Timeline
- Start date
- 2023-02-23
- Primary completion
- 2028-05-23
- Completion
- 2028-05-23
- First posted
- 2020-12-11
- Last updated
- 2026-01-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04663399. Inclusion in this directory is not an endorsement.