Biomarkers and Imaging Markers for ICH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: body sample collection and imaging scan.
- Who it may be relevant to
- Registry conditions: Intracerebral Hemorrhage. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biomarkers and Imaging Markers Screening for Intracerebral Hemorrhage Patients
Overview
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
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.
Interventions
- Other body sample collection and imaging scan
Primary outcome measures
- Biomarkers [Time frame: Immediately after collecting tissues]
- CT imaging features [Time frame: Within 1 month of onset]
- CTA imaging markers [Time frame: Within 1 month of onset]
- MR imaging markers [Time frame: Within 1 month of onset]
Secondary outcome measures (2)
- Glasgow Outcome Scale Extended (GOSE) [Time frame: 1 year]
- modified Rankin scale (mRS) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Individuals aged 18-80 years
- Hematoma size is more than 5 ml
- Evidence of a spontaneous ICH on CT scan
- Patient within 72 hours of ictus
- Glasgow Coma Scale (GCS) Score of 5-15.
- The history of hypertension
Exclusion criteria
- Individuals with age < 18 years or > 80 years
- Clear evidence that the hemorrhage is due to an aneurysm, arteriovenous malformation or other cerebrovascular diseases.
- ICH secondary to tumor or trauma..
- If the haematological effects of any previous anticoagulants are not completely reversed.
- Patients with heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Neurosurgery , Southwest Hospital, Third Military Medical University, — Chongqing
Identifiers
NCT: NCT06462274 · Neurosurg03