Biomarkers and Imaging Markers for ICH

NCT06462274 | Recruiting DMC

• 1 other identifier: Neurosurg03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (4)

• Biomarkers

  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.

  Immediately after collecting tissues

• CT imaging features

  Patients will undergo CT imaging examinations to evaluate the patient's hematoma volume, hematoma location, hematoma morphology, hematoma density and other imaging characteristics

  Within 1 month of onset

• CTA imaging markers

  The patient will undergo CTA imaging to evaluate the cerebrovascular features of the patient

  Within 1 month of onset

• MR imaging markers

  Magnetic resonance imaging was performed to evaluate the patient's hematoma morphology, signal, and edema around the hematoma cavity

  Within 1 month of onset

Secondary Outcomes (2)

• Glasgow Outcome Scale Extended (GOSE)

  1 year

• modified Rankin scale (mRS)

  1 year

Study Arms (2)

ICH group

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

Other: body sample collection and imaging scan

Control group

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

Other: body sample collection and imaging scan

Interventions

body sample collection and imaging scan OTHER

Control group; ICH group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Central laboratory biobank

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rong Hu, Ph.D

  Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Hu, Ph.D

CONTACT

86-23-68765761; huchrong@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Associate chief neurosurgeon

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: June 17, 2024
• Study Start: January 1, 2014
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CN (1)