Health TrialsbyHealthPanel

Biomarkers and Imaging Markers for ICH

ConditionIntracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSouthwest Hospital, China

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • body sample collection and imaging scan

    Other intervention

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: ICH group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after collecting tissues
2

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

Time frame
Within 1 month of onset
3

CTA imaging markers

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

Time frame
Within 1 month of onset
4

MR imaging markers

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

Time frame
Within 1 month of onset

Secondary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southwest Hospital, China

Lead sponsor

Source ClinicalTrials.gov
Apply now