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NCT Number: NCT06462274

Biomarkers and Imaging Markers for ICH

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chongqing, Chongqing Municipality, 400038, China

Location status: Recruiting

Location contact

Rong Hu, MD

CONTACT

[email protected]

+8615123917123

Rong Hu, MD

CONTACT

[email protected]

+8602368765912

Rong Hu, MD PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

body sample collection and imaging scan

Other

Primary outcomes

  1. 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.

  2. 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

  3. CTA imaging markers

    Time frame: Within 1 month of onset

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

  4. 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

Secondary outcomes

  1. Glasgow Outcome Scale Extended (GOSE)

    Time frame: 1 year

    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.

  2. modified Rankin scale (mRS)

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Hu, Ph.D

CONTACT

[email protected]

86-23-68765761

Sponsors and collaborators

Lead sponsor

Southwest Hospital, China

Other

Registry information

Official study title

Biomarkers and Imaging Markers Screening for Intracerebral Hemorrhage Patients

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2024
Registry last updated
Jun 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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