Intracerebral HemorrhageNCT06462274
Biomarkers and Imaging Markers for ICH
An observational study of Intracerebral Hemorrhage, run by Southwest Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- body sample collection and imaging scan
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Chongqing, Chongqing Municipality, 400038
Rong Hu, MD, +8615123917123, huchrong@aliyun.com
Rong Hu, MD, +8602368765912, huchrong@tmmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- body sample collection and imaging scan
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body sample collection and imaging scanOther
| Study group | Role | What they receive |
|---|---|---|
| ICH group | Patients with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset admitted to Southwest hospital. Receives: Other: body sample collection and imaging scan | |
| Control group | Age- and sex-matched healthy individuals were recruited from volunteers. Receives: Other: body sample collection and imaging scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Within 1 month of onset
CTA imaging markers
The patient will undergo CTA imaging to evaluate the cerebrovascular features of the patient
Measured: 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
Measured: Within 1 month of onset
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2014
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Hu, MD, Southwest Hospital, China
- Investigators
- Rong Hu, Ph.D, Principal investigator, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462274
- Sponsor's protocol ID
- Neurosurg03
- Status last verified
- Jun 2024
- First submitted
- 31 Jan 2016
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Imaging Markers Screening for Intracerebral Hemorrhage Patients
- ClinicalTrials.gov ID
- NCT06462274
- Acronym / sponsor ID
- Neurosurg03
- Conditions
- Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2014
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICH group | – | Other: body sample collection and imaging scanPatients with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset admitted to Southwest hospital. |
| Control group | – | Other: body sample collection and imaging scanAge- and sex-matched healthy individuals were recruited from volunteers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body sample collection and imaging scan | Other | Control group, ICH group |
Primary outcome
Biomarkers
Time frame: 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
Time frame: 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
Time frame: Within 1 month of onset
The patient will undergo CTA imaging to evaluate the cerebrovascular features of the patient
MR imaging markers
Time frame: Within 1 month of onset
Magnetic resonance imaging was performed to evaluate the patient's hematoma morphology, signal, and edema around the hematoma cavity
2 secondary outcomes
Glasgow Outcome Scale Extended (GOSE)
Time frame: 1 year
modified Rankin scale (mRS)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Hu, Ph.D principal investigator
Southwest Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Hu, Ph.D (86-23-68765761, huchrong@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers (time frame: Immediately after collecting tissues). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.