Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

Hopital Foch16 sites in 1 country4,000 target enrollmentJune 26, 2018

ConditionsStroke, Acute

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke, Acute
Sponsor: Hopital Foch
Enrollment: 4000
Locations: 16
Primary Endpoint: Clinical outcome
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

Registry

clinicaltrials.gov

Start Date

June 26, 2018

End Date

December 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 and older (i.e., candidates must have had their 18th birthday)
•Neuroimaging demonstrates acute ischemic stroke with large vessel proximal with the use of neuro-thrombectomy devices intended to restore blood flow
•No upper or lower limits of the neurological severity at baseline (NIHSS).
•With or without intravenous thrombolysis
•Oral informed consent (patient and/or trustworthy person)
•Non-inclusion Criteria:
•Pregnant or breast-feeding women
•Patient benefiting from a legal protection
•Non-membership of a national insurance scheme

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Clinical outcome

Time Frame: Day 90

modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.

Secondary Outcomes

ASPECT (Alberta Stroke Program Early CT score)(Day O)
Efficacy on revascularization (>= mTICI 2b)(Day 1)
Hematoma rate(Day 1)
Mortality rate(Day 90)
Parametric imaging(Day 0)
Imaging data(Day 1)
Blood sampling for research purpose(Day 0)
Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)(Day 1)
Hemorrhage evaluated by imagery(Day 0)
Efficacy on clinical outcome (mRS=0-1)(Day 90)
Complication rate(Day 0)
Efficacy on functional independence (mRS 0-2)(Day 90)