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CIRP and Cathepsin B in Neuroinflammation After Intracerebral Hemorrhage (CIRP-ICH)

2026년 6월 22일 업데이트: Xuanwu Hospital, Beijing

A Prospective Observational Case-Control Study of Peripheral Blood CIRP, Cathepsin B, and Related Inflammatory Biomarkers in Patients With Intracerebral Hemorrhage

This is a single-center, investigator-initiated, prospective observational case-control study. Patients with intracerebral hemorrhage and healthy controls will be enrolled at Xuanwu Hospital, Capital Medical University. Peripheral venous blood samples will be collected for measurement of CIRP, Cathepsin B, and related inflammatory biomarkers. Clinical and imaging data will also be collected in the intracerebral hemorrhage group. The study aims to compare biomarker levels between patients with intracerebral hemorrhage and healthy controls and to explore the potential role of these biomarkers in neuroinflammation after intracerebral hemorrhage. No investigational treatment will be administered.

연구 개요

상태

아직 모집하지 않음

상세 설명

Intracerebral hemorrhage (ICH) is a severe subtype of stroke with high mortality and disability. In addition to the primary mass effect caused by hematoma, secondary brain injury, especially neuroinflammation, is considered a major contributor to neurological deterioration after ICH. Cold-inducible RNA-binding protein (CIRP) is a stress-related molecule with pro-inflammatory properties, while Cathepsin B is a lysosomal protease involved in inflammasome activation, cellular stress, and tissue injury. Experimental evidence suggests that both CIRP and Cathepsin B may participate in inflammatory amplification after ICH, but their expression patterns and clinical relevance in patients with ICH remain insufficiently characterized.

This study is a single-center, investigator-initiated, prospective observational case-control study conducted at Xuanwu Hospital, Capital Medical University. A total of 60 participants will be enrolled, including 40 patients with intracerebral hemorrhage and 20 healthy controls. The ICH group will consist of adult patients with supratentorial intracerebral hemorrhage confirmed by CT or MRI, admitted within 24 hours after symptom onset, with hematoma volume less than 30 mL and no surgical treatment. Healthy controls will be recruited from the hospital health examination center.

For the ICH group, demographic information, medical history, time from onset to admission, vital signs, laboratory test results, imaging findings, and treatment information will be collected. For the healthy control group, demographic information, medical history, and health examination-related information will be collected. Peripheral venous blood samples (4-5 mL) will be obtained from both groups. In the ICH group, residual blood samples generated during routine clinical care will be used whenever possible; if residual samples are insufficient and study needs require, a small additional blood sample may be collected together with routine blood drawing after informed consent. In the healthy control group, one peripheral venous blood sample will be collected after informed consent. All samples will be processed, aliquoted, and stored at low temperature for subsequent measurement of CIRP, Cathepsin B, and related inflammatory biomarkers.

The primary objective of the study is to compare peripheral blood CIRP levels between the ICH group and the healthy control group. Secondary objectives include comparing peripheral blood Cathepsin B and related inflammatory biomarkers between the two groups, and exploring the potential clinical significance of these biomarkers in neuroinflammation after ICH. No investigational drugs, biologics, or devices will be administered in this study. The results are expected to provide clinical evidence for future mechanistic and translational studies targeting CIRP- and Cathepsin B-related pathways in ICH.

연구 유형

관찰

등록 (추정된)

60

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

샘플링 방법

비확률 샘플

연구 인구

Adults with intracerebral hemorrhage admitted to Xuanwu Hospital, Capital Medical University, and age-eligible healthy controls recruited from the hospital health examination center. The intracerebral hemorrhage group includes patients with supratentorial, non-surgical intracerebral hemorrhage confirmed by CT or MRI and admitted within 24 hours after symptom onset. The healthy control group includes adults without stroke or other major neurological diseases.

설명

Inclusion Criteria:

Intracerebral hemorrhage group:

Age 18 years or older Diagnosis of intracerebral hemorrhage confirmed by head CT or MRI Supratentorial hemorrhage No surgical treatment Hematoma volume less than 30 mL Admission within 24 hours after symptom onset The participant or the legally authorized representative/next of kin is able to provide written informed consent

Healthy control group:

Age 18 years or older Recruited from the hospital health examination center No history of stroke, intracerebral hemorrhage, cerebral infarction, or other major neurological diseases No severe active infection, severe immune disease, hematologic disease, or end-stage severe heart, liver, or renal failure No acute infection, trauma, or other obvious stress state within the previous 2 weeks Able to provide written informed consent

Exclusion Criteria:

Intracerebral hemorrhage group:

Traumatic intracerebral hemorrhage Secondary intracerebral hemorrhage caused by brain tumor, cerebrovascular malformation, aneurysm, or hemorrhagic transformation of infarction Severe active infection, severe immune disease, or hematologic disease End-stage severe heart, liver, or renal failure Pregnant or lactating women Any other condition judged unsuitable by the investigator

Healthy control group:

History of stroke, intracranial hemorrhage, brain tumor, or other major neurological diseases Severe active infection, severe immune disease, or hematologic disease End-stage severe heart, liver, or renal failure Pregnant or lactating women Any other condition judged unsuitable by the investigator

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Intracerebral Hemorrhage Group
Adults with intracerebral hemorrhage confirmed by head CT or MRI, admitted within 24 hours after symptom onset, and prospectively enrolled after informed consent. Peripheral venous blood samples (4-5 mL) will be collected, and clinical and imaging data will also be obtained.
Peripheral venous blood sample collection for biomarker measurement only; no investigational treatment is administered.
Healthy Control Group
Age-eligible healthy controls recruited prospectively from the hospital health examination center after informed consent. One peripheral venous blood sample (4-5 mL) will be collected, together with basic demographic and health-related information.
Peripheral venous blood sample collection for biomarker measurement only; no investigational treatment is administered.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Peripheral Blood CIRP Level
기간: Within 24 hours after enrollment for the intracerebral hemorrhage group; once at baseline on the day of blood collection for healthy controls.
Comparison of peripheral blood CIRP levels between the intracerebral hemorrhage group and the healthy control group.
Within 24 hours after enrollment for the intracerebral hemorrhage group; once at baseline on the day of blood collection for healthy controls.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2027년 7월 1일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 15일

QC 기준을 충족하는 최초 제출

2026년 6월 22일

처음 게시됨 (실제)

2026년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 22일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • XWH-7262054-ICH
  • 7262054 (기타 보조금/기금 번호: General Program of the Beijing Natural Science Foundation)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

IPD will not be shared due to participant privacy and confidentiality considerations. This is a single-center study involving sensitive clinical and biospecimen-derived data, and no formal external data-sharing plan has been established. Results will be reported in aggregate form only.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

뇌내출혈에 대한 임상 시험

Blood Sample Collection에 대한 임상 시험

3
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