Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE)

Stroke Clinical Trial

— IMMUNOSTROKE  

Official title:

Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04701619
• Other study ID #: BMR_2020_31
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2024
• Est. completion date: May 15, 2026

Study information

• Verified date: June 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Benjamin Maier
• Phone: 0148036556
• Email: nmaier[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 15, 2026
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Presenting an ISCHEMIC STROKE for which reperfusion treatment is indicated according to European and North American recommendations (intraveinous thrombolysis or mechanical thrombectomy or a combination of both)

Exclusion Criteria:

• Contraindication to performing a cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating the performance of MRI)

• Intracranial haemorrhage associated with AIC on initial imaging

• 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 ischemic stroke

• Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breastfeeding woman).

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Immuno-inflammatory profile description in patients with ischemic stroke
Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment	Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA preconfigurated panels for inflammatory biomarkers.	Up to year