Clinical trial NCT06498778: Etiology and Prognosis of sICH Based on Hemorrhage Location
Official title: Prediction of Etiology and Prognosis Based on Hematoma Location of Spontaneous Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Intracerebral Hemorrhage
Keywords: Normative analysis; Lesion-symptom mapping; Radiomics; Etiological classification; Machine learning
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study encompassed the collection of sICH patients. The confirmation of intracranial hemorrhage was achieved through NCCT.

Brief summary: The investigators retrospectively collected participants with spontaneous cerebral hemorrhage(sICH) from January 2015 to December 2019 for training and internal validation. Clinical and imaging data were collected. Modified Rankin Scale (mRS) scores were determined good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6". The location features of sICH were extracted by symptom mapping. Noncontrast computed tomography images of patients and hematoma masks were registered with standard human brain templates to identify specific affected brain regions. Then a probability map of hemorrhage for different causes and prognosis is generated. PyRadiomics was used to extract the radiomic features, integrate radiomic and clinical features into multiple logistic regression models, and develop and validate optimal etiological and prognostic models. Further tests were performed in an independent cohort. The area under the working characteristic curve (AUC), sensibility, specificity were used to evaluate the reliability of the model.


Eligibility criteria: Inclusion Criteria:

* The confirmation of intracranial hemorrhage was achieved through NCCT.

Exclusion Criteria:

* They presented with secondary hemorrhage resulting from head trauma, hemorrhagic transformation of ischemic infarction, brain tumors, or exhibited abnormalities in blood coagulation, liver, kidney function, or were subject to drug-induced cerebral hemorrhage
* Only postoperative CT images were available
* Lost follow-up records
* CT image artifacts

Primary outcomes:
measure: Modified Rankin Scale (mRS) scores
timeFrame: follow-ups at twelve months post sICH event
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Deparetment of Radiology, Jinling Hospital
name: Guangming Lu
role: STUDY_DIRECTOR
References:
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