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

Artificial Intelligence Clinical Trial

Official title:

Capital's Funds for Health Improvement and Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424614
• Other study ID #: 2022-2-1074
• Status: Recruiting
• Start date: May 13, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2022
• Source: Beijing Neurosurgical Institute
• Contact: Shengjun Sun
• Phone: 13611293369
• Email: sunshengjun0212[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Cerebral Hemorrhage
• Hemorrhage
• Prognosis

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

References & Publications (9)

Fu F, Sun S, Liu L, Gu H, Su Y, Li Y. Iodine Sign as a Novel Predictor of Hematoma Expansion and Poor Outcomes in Primary Intracerebral Hemorrhage Patients. Stroke. 2018 Sep;49(9):2074-2080. doi: 10.1161/STROKEAHA.118.022017. — View Citation

Gregório T, Pipa S, Cavaleiro P, Atanásio G, Albuquerque I, Chaves PC, Azevedo L. Prognostic models for intracerebral hemorrhage: systematic review and meta-analysis. BMC Med Res Methodol. 2018 Nov 20;18(1):145. doi: 10.1186/s12874-018-0613-8. — View Citation

Guo R, Zhang R, Liu R, Liu Y, Li H, Ma L, He M, You C, Tian R. Machine Learning-Based Approaches for Prediction of Patients' Functional Outcome and Mortality after Spontaneous Intracerebral Hemorrhage. J Pers Med. 2022 Jan 14;12(1). pii: 112. doi: 10.3390/jpm12010112. — View Citation

Menon G, Johnson SE, Hegde A, Rathod S, Nayak R, Nair R. Neutrophil to lymphocyte ratio - A novel prognostic marker following spontaneous intracerebral haemorrhage. Clin Neurol Neurosurg. 2021 Jan;200:106339. doi: 10.1016/j.clineuro.2020.106339. Epub 2020 Oct 28. — View Citation

Morotti A, Arba F, Boulouis G, Charidimou A. Noncontrast CT markers of intracerebral hemorrhage expansion and poor outcome: A meta-analysis. Neurology. 2020 Oct 6;95(14):632-643. doi: 10.1212/WNL.0000000000010660. Epub 2020 Aug 26. — View Citation

Pszczolkowski S, Manzano-Patrón JP, Law ZK, Krishnan K, Ali A, Bath PM, Sprigg N, Dineen RA. Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage. Eur Radiol. 2021 Oct;31(10):7945-7959. doi: 10.1007/s00330-021-07826-9. Epub 2021 Apr 16. — View Citation

Tseng WC, Wang YF, Wang TG, Hsiao MY. Early spot sign is associated with functional outcomes in primary intracerebral hemorrhage survivors. BMC Neurol. 2021 Mar 20;21(1):131. doi: 10.1186/s12883-021-02146-3. — View Citation

Wang J, Wang W, Liu Y, Zhao X. Associations Between Levels of High-Sensitivity C-Reactive Protein and Outcome After Intracerebral Hemorrhage. Front Neurol. 2020 Oct 6;11:535068. doi: 10.3389/fneur.2020.535068. eCollection 2020. — View Citation

Xie H, Ma S, Wang X, Zhang X. Noncontrast computer tomography-based radiomics model for predicting intracerebral hemorrhage expansion: preliminary findings and comparison with conventional radiological model. Eur Radiol. 2020 Jan;30(1):87-98. doi: 10.1007/s00330-019-06378-3. Epub 2019 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient outcome	Neurological recovery status was measured by the modified Rankin Scale	3 month