Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack

Shinichiro Uchiyama; Katsue Suzuki-Inoue; Hideo Wada; Yasushi Okada; Teruyuki Hirano; Takehiko Nagao; Hiroyuki Kinouchi; Ryo Itabashi; Haruhiko Hoshino; Koichi Oki; Yutaka Honma; Nobuo Ito; Hiroshi Sugimori; Masahide Kawamura

doi:10.1136/bmjopen-2023-073708

Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack

BMJ Open. 2023 Sep 18;13(9):e073708. doi: 10.1136/bmjopen-2023-073708.

Authors

Affiliations

¹ Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan suchiyama@iuhw.ac.jp.
² Department of Clinical and Laboratory Medicine, University of Yamanashi, Chuo, Japan.
³ Department of General and Laboratory Medicine, Mie Prefectural General Medical Centre, Yokkaichi, Japan.
⁴ Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Centre, Fukuoka, Japan.
⁵ Department of Stroke and Cerebrovascular Medicine, Kyorin University, Mitaka, Japan.
⁶ Department of Neurology, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.
⁷ Department of Neurosurgery, University of Yamanashi, Chuo, Japan.
⁸ Division of Neurology & Gerontology, Iwate Medical University, Shiwa, Japan.
⁹ Department of Neurology, Tokyo Saiseikai Central Hospital, Tokyo, Japan.
¹⁰ Department of Neurology, Showa General Hospital, Kodaira, Japan.
¹¹ Department of Neurology, Mie Prefectural General Medical Centre, Yokkaichi, Japan.
¹² Department of Research and Development, LSI Medience Corporation, Tokyo, Japan.

Abstract

Introduction: Soluble C-type lectin-like receptor 2 (sCLEC-2) is a new biomarker for platelet activation, which can be easily measured by usual blood collection. We conducted the CLECSTRO, a prospective, observational cohort study, to evaluate the clinical implications of sCLEC-2 in patients with acute ischaemic stroke (AIS) and transient ischaemic attack (TIA).

Methods and analysis: The participants are patients with AIS/TIA and control patients required for differentiation from AIS/TIA. The target population is 600, including the patients and controls, who would be recruited from eight stroke centres across Japan. The inclusion criteria are AIS within 24 hours of onset and a modified Rankin Scale (mRS) score of 0-2, TIA within 7 days of onset, and contemporary patients required for differentiation from AIS/TIA. Plasma sCLEC-2 will be 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 or at discharge 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 outcome (mRS) at 7 days and 3 months.

Ethics and dissemination: This study was approved by the Ethical Committee of the University of Yamanashi as the central ethical committee in agreement with the ethical committees of all collaborative stroke centres. Informed consent will be obtained by an opt-out form from the patients at each stroke centre according to the Ethical Guidelines for Medical and Biological Research Involving Human Subjects by the Japanese Ministry of Health, Labour and Welfare.

Trial registration numbers: NCT05579405, UMIN000048954.

Keywords: Stroke; Stroke medicine.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Brain Ischemia* / diagnosis
Humans
Ischemic Attack, Transient* / diagnosis
Ischemic Stroke*
Lectins, C-Type
Multicenter Studies as Topic
Observational Studies as Topic
Prospective Studies
Stroke* / diagnosis

Substances

Lectins, C-Type
CLEC1B protein, human

Associated data

ClinicalTrials.gov/NCT05579405
UMIN-CTR/UMIN000048954