Purpose:
We conducted a prospective, multicenter, observational cohort study, to evaluate the clinical implications of soluble C-type lectin-like receptor 2 (sCLEC-2), a new biomarker for platelet activation, which is easily measurable in usual blood sampling, in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA).
Methods:
The participants were patients with AIS/TIA and control patients required for differentiation from AIS/TIA. The target population was 600, including the patients and controls, who has been recruited from eight stroke centers across Japan. The inclusion criteria were AIS within 24 hours of onset and a modified Rankin Scale (mRS) score of 0–2, TIA within 7 days of onset, and contemporary patient controls. Plasma sCLEC-2 was measured by high-sensitive chemiluminescent enzyme immunoassay using residual blood samples from routine laboratory examinations at the first visit in all patients and 7 days later in patients with AIS/TIA. The outcomes include plasma levels of sCLEC-2 in patients with AIS/TIA and controls, sCLEC-2/D-dimer ratio in non-cardioembolic and cardioembolic AIS/TIA, correlation of sCLEC-2 with recurrence or worsening of stroke, severity of stroke, infarct size, ABCD2 score in TIA, and mRS at 7 days and 3 months.
Results:
Recruitment of the target population has been completed. The baseline data will be collected within this year. The final results will be presented next year.
Conclusion:
sCLEC-2 has the potential to serve as a novel and broadly applicable biomarker, thereby contributing to the progress of precision medicine in the pathophysiology, diagnosis, and management of AIS and TIA (NCT05579405).