Biomarkers and Imaging Markers for ICH

NCT ID: NCT06462274

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2026-12-01

Brief Summary

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Intracerebral hemorrhage (ICH) is a subtype of stroke associated with high mortality and disability. Basic and clinical research has contributed to our understanding of the complex pathophysiology in ICH. However, questions regarding acute diagnosis, therapeutic decisions, and prognostication of ICH remain unanswered. Molecular biomarkers and imaging markers have revolutionalized diagnosis and treatment of many diseases, such as troponin use in myocardial infarction and magnetic resonance imaging (MRI) scan in ischemic stroke. Therefore, the investigators aim to discovery the potential biomarkers by screening samples of blood, cerebral spinal fluid, urine, saliva, and even tissues (if available) from ICH patients, and imaging markers via serial multimodality imaging scans such as computed tomography(CT), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), positron emission tomography (PET), etc. These molecular and imaging markers would assist in contributing additional information to current tools for onset warning, diagnosis, therapy monitoring, risk stratification, intervention and prognosis for ICH patients.

Detailed Description

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Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Today little is known about the characteristic changes in molecules from body samples and pictures from multimodality imaging scans. In this study, the investigators aim to reveal the potential biomarkers by screening samples of blood, cerebral spinal fluid, urine, saliva, and even tissues (if available) from ICH patients, and imaging markers via serial multimodality imaging scans such as computed tomography(CT), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), positron emission tomography (PET), etc, which will bring insights into pathophysiological mechanisms and addition of new tools for onset warning, diagnosis, therapy monitoring, risk stratification, intervention and prognosis for ICH patients.

Conditions

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Intracerebral Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICH group

Patients with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset admitted to Southwest hospital.

body sample collection and imaging scan

Intervention Type OTHER

Control group

Age- and sex-matched healthy individuals were recruited from volunteers.

body sample collection and imaging scan

Intervention Type OTHER

Interventions

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body sample collection and imaging scan

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Individuals aged 18-80 years
2. Hematoma size is more than 5 ml
3. Evidence of a spontaneous ICH on CT scan
4. Patient within 72 hours of ictus
5. Glasgow Coma Scale (GCS) Score of 5-15.
6. The history of hypertension

Exclusion Criteria

1. Individuals with age \< 18 years or \> 80 years
2. Clear evidence that the hemorrhage is due to an aneurysm, arteriovenous malformation or other cerebrovascular diseases.
3. ICH secondary to tumor or trauma..
4. If the haematological effects of any previous anticoagulants are not completely reversed.
5. Patients with heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Rong Hu, MD

Associate professor, Associate chief neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rong Hu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Locations

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Department of Neurosurgery , Southwest Hospital, Third Military Medical University,

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rong Hu, Ph.D

Role: CONTACT

86-23-68765761

Facility Contacts

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Rong Hu, MD

Role: primary

+8615123917123

Rong Hu, MD

Role: backup

+8602368765912

Other Identifiers

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Neurosurg03

Identifier Type: -

Identifier Source: org_study_id

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