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sCLEC-2 in Stroke Study

CLECSTRO Study (LM22-01 Clinical performance Study) - CLECSTRO Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000048954
Enrollment
600
Registered
2022-10-01
Start date
2022-10-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke and transient ischemic attack

Interventions

None listed

Sponsors

University of Yamanashi
Lead Sponsor
Iwate Medical University, Kyorin University Hospital, Showa General Hospital, Kyushu Medical Center, Saiseikai Central Hospital, Nippon Medical School Musashikosugi Hospital, Mie Prefectural General Medical Center, LSI Medience Co.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who visited the research institution during the period from the date of permission of the head of the research institution to September 30, 2025 2) Inclusion criteria by group -AIS group: patients diagnosed with ischemic stroke within 24 hours after onset and an mRS of 0-2 before the onset -TIA group: patients diagnosed with TIA by two physicians based on the NINDS-III diagnostic criteria and within 7 days of attack (no evidence of acute infarction, and episodes of focal neurological dysfunction resolved within 24 hours) -Control group: patients with suspected AIS or TIA but diagnosed with another disease by two physicians

Exclusion criteria

Exclusion criteria: 1) Concomitant conditions that may affect platelets or blood coagulation, such as acute thrombosis of other organs, hematologic disorders, or pregnancy 2) Cerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, other trauma, postoperative cases, and bleeding disorders 3) Severe infectious disease 4) Exclusion criteria by group AIS and TIA groups: patients whose onset time is unknown except for those for whom the onset occurred during sleep 5) Patients who are deemed inappropriate for this study by a physician 6) Inadequate condition of the collected specimens -Coagulation has occurred in a citrated blood collection tube -Too little or too much blood sampling volume in citrated plasma -Total bilirubin level of 10 mg/dL or more

Design outcomes

Primary

MeasureTime frame
Soluble C-type lectin-like receptor 2 level for the difference between patients (ischemic stroke or transient ischemic attack) and controls (neurological patients to require differentiation from ischemic stroke or transient ischemic attack)

Secondary

MeasureTime frame
Soluble C-type lectin-like receptor 2 level for the (1) correlation with severity of stroke,(2) correlation with size of infarct, (3) correlation with ABCD2 score in transient ischemic attack, (4) relationship between treatment effect and worsening or recurrence,(5) in the ratio to D-dimer between cardiogenic and non-cardiogenic etiology, (6) difference between TOAST subtypes of ischemic stroke, and (7) correlation with outcome(mRS and major vascular events) at 3 months

Countries

Japan

Contacts

Public ContactKatsue Suzuki-Inoue

University of Yamanashi Department of Clinical and Laboratory Medicine

katsuei@yamanashi.ac.jp+81-55-273-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026