sCLEC-2 in Stroke Study
CLECSTRO
Soluble C-type Lectin-Like Receptor 2 in Stroke Study
3 other identifiers
observational
600
1 country
9
Brief Summary
Any platelet function tests have not been widely used in the clinical practice of acute cerebrovascular disease because of the concerns in repeatability, economic performance, and simplicity. Soluble C-type lectin-like receptor 2 (sCLEC-2) is a new marker for platelet activation, which can be easily measured by usual blood collection in routine clinical practice. We planned the sCLEC-2 in Stroke (CLECSTRO), which is a prospective cohort study in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA). We planned the sCLEC-2 in Stroke (CLECSTRO), which is a prospective cohort study in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA). The purpose of this study is to evaluate the clinical utility of sCLEC-2 as a biomarker for pathophysiology, differential diagnosis, prediction of prognosis, and monitoring of antiplatelet therapy in patients with AIS and TIA. Subjects are patients with AIS or TIA and control patients required for differentiation from AIS or TIA. The target population is 600 including the patients and the controls. The outcomes include difference in plasma sCLEC-2 level between patients with AIS or TIA and patient controls, correlation between sCLEC-2 after antithrombotic therapy and recurrence or worsening of stroke, difference in sCLEC-2/D-dimer ratio between non-cardioembolic and cardioembolic AIS or TIA, and correlation between baseline sCLEC-2 and outcome (modified Rankin scale score) after 3 months. sCLEC-2 could be a widely useful biomarker to contribute to the progress of precision medicine in clinical practice of AIS and TIA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2022
CompletedStudy Start
First participant enrolled
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 13, 2022
October 1, 2022
1.1 years
October 10, 2022
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Diagnosis of Acute Ischemic Stroke and TIA
The ischemic stroke group and TIA group will be compared with the control group to evaluate whether the sCLEC-2 level contributes to the improvement of the diagnostic accuracy of ischemic stroke and TIA.
On admission before treatment
Evaluation of Antithrombotic Therapy
The post-treatment sCLEC-2 levels in patients with acute ischemic cerebrovascular disorders will be compared between patients without worsening/recurrence (effective treatment group) and those with worsening/recurrence during treatment (ineffective treatment group) to evaluate whether sCLEC-2 measurements contribute to the evaluation of the efficacy of antithrombotic therapy.
On 7+/-1 days after admission
Comparison of sCLEC-2 /D-dimer ratio between cardiogenic and non-cardiogenic etiologies
The ischemic stroke group and TIA group will be classified into cardiogenic and non-cardiogenic etiologies based on the TOAST classification to evaluate whether the sCLEC-2/ D-dimer ratio contributes to the accuracy of subtype classification.
On admission before treatment
Correlation of sCLEC-2 levels on admission with outcome of ischemic stroke and TIA at 3 months
The relationships between the sCLEC-2 levels on admission and outcomes at 3 months in the ischemic stroke and TIA groups will be evaluated.
On admission before treatment and 3 months after onset
Secondary Outcomes (2)
Correlation of sCLEC-2 levels on admission with severity of ischemic stroke or TIA
On admission before treatment
Difference of sCLEC-2 levels among TOAST subtypes of ischemic stroke
On admission before treatment
Study Arms (3)
Acute Ischemic Stroke
Ischemic stroke within 24 hours of onset and modified Rankin Scale 0 to 2
Transient ischemic attack
Transient ischemic attack without MRI positivity within 7 days of onset
Patient Control
Contemporary patients with neurological symptoms required for differentiation from ischemic stroke or transient ischemic attack
Eligibility Criteria
Patients who visit to the department specialized for stroke
You may qualify if:
- Ischemic stroke within 24 hours of onset and modified Rankin Scale 0 to 2
- Transient ischemic attack without MRI positivity within 7 days of onset
- Contemporary patients required for differentiation from ischemic stroke or transient ischemic attack
You may not qualify if:
- Platelet or coagulation abnormalities
- Hemorrhagic stroke, head or other trauma, post-surgery, and hemorrhagic tendency
- Severe infection
- Inappropriate patients who were judged by doctors
- Poor status of blood samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
LSI Medience Co.
Katori-shi, Chiba, 289-2247, Japan
Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
Iwate Medical University
Shiwa-gun, Iwate, 028-3694, Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533, Japan
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, 510-8561, Japan
Showa General Hospital
Kodaira-shi, Tokyo, 187-8510, Japan
Saiseikai Central Hospital
Minato-ku, Tokyo, 108-0073, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611, Japan
University of Yamanashi
Chuo-shi, Yamanashi, 409-3898, Japan
Related Publications (1)
Uchiyama S, Suzuki-Inoue K, Wada H, Okada Y, Hirano T, Nagao T, Kinouchi H, Itabashi R, Hoshino H, Oki K, Honma Y, Ito N, Sugimori H, Kawamura M. 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.
PMID: 37723115DERIVED
Biospecimen
plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katsue Suzuki-Inoue, M.D., Ph.D.
University of Yamanashi
- STUDY CHAIR
Shinichiro Uchiyama, M.D.
Sanno Medical Center/LSI Medience Co.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Department of Clinical and Laboratory Medicine
Study Record Dates
First Submitted
October 10, 2022
First Posted
October 13, 2022
Study Start
October 11, 2022
Primary Completion
December 1, 2023
Study Completion
December 31, 2024
Last Updated
October 13, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP