Hôpital Fondation Adolphe de Rothschild
Paris, 75019, France
Location status: Recruiting
NCT Number: NCT04663399
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Paris, 75019, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non inclusion Criteria:
Exclusion criteria
None.
The immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Amélie Yavchitz, MD
CONTACT
Benjamin Maier, MD
CONTACT
Fondation Ophtalmologique Adolphe de Rothschild
Network
IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy
Acronym: IMPRESS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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