Biomarkers and Imaging Markers for ICH

Biomarkers and Imaging Markers Screening for Intracerebral Hemorrhage Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Other: body sample collection and imaging scan

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Rong Hu, Ph.D; Phone Number: 86-23-68765761; Email: huchrong@aliyun.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
      • Contact: Rong Hu, MD; Phone Number: +8615123917123; Email: huchrong@aliyun.com
      • Principal Investigator: Rong Hu, MD PHD
      • Contact: Rong Hu, MD; Phone Number: +8602368765912; Email: huchrong@tmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Outcome Scale Extended (GOSE)	GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.	1 year
modified Rankin scale (mRS)	Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.	1 year

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: Rong Hu, Ph.D, Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: Neurosurg03