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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04663399
Other study ID # BMR_2020_32
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2023
Est. completion date December 15, 2024

Study information

Verified date July 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Benjamin Maier
Phone 0148036556
Email bmaier@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 15, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Presenting an acute ischemic stroke for which treatment by mechanical thrombectomy is indicated according to European and North American recommendations (associated or not with intravenous thrombolysis) Exclusion Criteria: - Intracranial haemorrhage associated with acute ischemic stroke on initial imaging - Contraindication or non-indication to a mechanic thrombectomy - Immunosuppressive treatment or corticosteroid therapy on admission of the patient - Pre-existing neurological disability limiting the neurological assessment to 3 months (mRS>2 on admission) - Dementia known and diagnosed pre-existing at acute ischemic stroke - Pregnant or breastfeeding woman

Study Design


Intervention

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.

Locations

Country Name City State
France Hôpital Fondation Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie. 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. 21 months
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