Clinical trial NCT06462274: Biomarkers and Imaging Markers for ICH
Official title: Biomarkers and Imaging Markers Screening for Intracerebral Hemorrhage Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracerebral Hemorrhage
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Individuals aged 18-80 years
2. Evidence of a spontaneous ICH on CT scan
3. Patient within 72 hours of ictus
4. Glasgow Coma Scale (GCS) Score of 5-15.
5. The history of hypertension

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Biomarkers
timeFrame: Immediately after collecting tissues
measure: CT imaging features
timeFrame: Within 1 month of onset
measure: CTA imaging markers
timeFrame: Within 1 month of onset
measure: MR imaging markers
timeFrame: Within 1 month of onset
Secondary outcomes:
measure: Glasgow Outcome Scale Extended (GOSE)
timeFrame: 1 year
measure: modified Rankin scale (mRS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Rong Hu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: