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- Essai clinique NCT07665255
CIRP and Cathepsin B in Neuroinflammation After Intracerebral Hemorrhage (CIRP-ICH)
A Prospective Observational Case-Control Study of Peripheral Blood CIRP, Cathepsin B, and Related Inflammatory Biomarkers in Patients With Intracerebral Hemorrhage
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Guohua Wang, MD, PhD
- Numéro de téléphone: +86 13581749398
- E-mail: wangguohua@xwhosp.org
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Peripheral Blood CIRP Level
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Hémorragie
- Inflammation
- Hémorragies intracrâniennes
- Conditions pathologiques, signes et symptômes
- Maladies neuroinflammatoires
- Hémorragie cérébrale
Autres numéros d'identification d'étude
- XWH-7262054-ICH
- 7262054 (Autre subvention/numéro de financement: General Program of the Beijing Natural Science Foundation)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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