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

2026年6月22日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

観察的

入学 (推定)

60

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Peripheral Blood CIRP Level
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年6月15日

QC基準を満たした最初の提出物

2026年6月22日

最初の投稿 (実際)

2026年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月24日

QC基準を満たした最後の更新が送信されました

2026年6月22日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • XWH-7262054-ICH
  • 7262054 (その他の助成金/資金番号:General Program of the Beijing Natural Science Foundation)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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