Study on the Prognostic Prediction Model of Patients With Acute Intracerebral Hemorrhage by Artificial Intelligence

Sponsor
Beijing Neurosurgical Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05424614
Collaborator
(none)
150
1
31.6
4.7

Study Details

Study Description

Brief Summary

Spontaneous intracerebral hemorrhage(SICH) is the most lethal and disabling stroke. Timely and accurate assessment of patient prognosis could facilitate clinical decision making and stratified management of patients and is important for improving patient clinical prognosis. However, current studies on the prediction of prognosis of patients with SICH are limited and only include a single variable, with less precise results and inconvenient clinical application, which may lead to delays in effective patient treatment. Our group's previous studies on SICH showed that hematoma heterogeneity and the degree of contrast extravasation within the hematoma are closely related to the clinical outcome of patients, but they are difficult to describe quantitatively based on imaging signs. Based on this, we propose to use radiomics to quantitatively extract hematoma features from NCCT and CTA images, combine them with patients' clinical information and laboratory tests, study their relationship with the prognosis of cerebral hemorrhage, and use artificial intelligence to establish a rapid and accurate prognostic prediction model for patients with SICH, which is of great significance to guide clinical individualized treatment.

Condition or Disease Intervention/Treatment Phase
  • Other: Functional outcome follow-up of patients

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Capital's Funds for Health Improvement and Research
Actual Study Start Date :
May 13, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
intracerebral hemorrhage group

Patients with the intracerebral hemorrhage who presented to the hospital within 24 hours of symptom onset

Other: Functional outcome follow-up of patients
Patients were followed up by telephone after discharge, every 4 weeks, until the end of the 3-month follow-up. Their functional status was determined based on the MRS score (modified Rankin Scale). Those with less than 3 points were defined as having a good prognosis, and those with more than 3 points were defined as having a poor prognosis

Outcome Measures

Primary Outcome Measures

  1. patient outcome [3 month]

    Neurological recovery status was measured by the modified Rankin Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. aged 18-80 years; 2. patients diagnosed with acute cerebral hemorrhage by CT examination; 3. complete non-contrast CT and CTA images; 4. the time interval from onset to the first baseline CT and CTA examination is less than 6 hours; 5. follow-up data within 3 months; 6. agree and sign a written document.
Exclusion Criteria:
    1. Patients with secondary aneurysm hemorrhage; 2. Patients with secondary hemorrhage of cerebrovascular malformation; 3. Patients with dissecting aneurysm hemorrhage; 4. Patients with cerebral infarction hemorrhage transformation; 5. Patients lost to follow-up within 3 months; 6. CT or CTA images have a heavy artefact.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100070

Sponsors and Collaborators

  • Beijing Neurosurgical Institute

Investigators

  • Principal Investigator: Shengjun Sun, Beijing Neurosurgical Instuitute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier:
NCT05424614
Other Study ID Numbers:
  • 2022-2-1074
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022