Biomarkers and Imaging Markers for ICH

NCT06462274 · tracked via the Priya Life Science China tracker

Sponsor

Southwest Hospital, China

Phase

Observational

Started

2014-01-01

Last updated

2024-06-17

Condition(s) studied

Intracerebral Hemorrhage

Investigational drug(s) / intervention(s)

body sample collection and imaging scan

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Biomarkers — Immediately after collecting tissues
Diseased tissue from the patient is collected at the time of hematoma removal. These tissues are then immediately prepared and detected by proteome mass spectrometry. The results will be further analyzed by bioinformatics analysis to reveal the expression of proteins in the diseased tissues of patients with intracerebral hemorrhage as potential biomarkers.
CT imaging features — Within 1 month of onset
Patients will undergo CT imaging examinations to evaluate the patient's hematoma volume, hematoma location, hematoma morphology, hematoma density and other imaging characteristics
CTA imaging markers — Within 1 month of onset
The patient will undergo CTA imaging to evaluate the cerebrovascular features of the patient
MR imaging markers — Within 1 month of onset
Magnetic resonance imaging was performed to evaluate the patient's hematoma morphology, signal, and edema around the hematoma cavity

Trial sites (1)

Facility	City	Region	Status
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,	Chongqing	Chongqing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06462274 on ClinicalTrials.gov ↗ ← All trials in China