Etiology and Prognosis of sICH Based on Hemorrhage Location

NCT06498778 | Completed

• 1 other identifier: 2022DZGZR-074
• Study Type: observational
• Target: 698
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Intracerebral Hemorrhage

Keywords

Normative analysis; Lesion-symptom mapping; Radiomics; Etiological classification; Machine learning

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale (mRS) scores

  Good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6"

  follow-ups at twelve months post sICH event

Study Arms (2)

good outcome

Modified Rankin Scale (mRS) scores were determined based on clinical examinations or telephone follow-ups at twelve months post sICH event. Consistent with prior literature, we defined good outcome as "mRS = 0-2".

poor outcome

Modified Rankin Scale (mRS) scores were determined based on clinical examinations or telephone follow-ups at twelve months post sICH event. Consistent with prior literature, we defined poor outcome as "mRS = 3-6".

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This retrospective study encompassed the collection of sICH patients. The confirmation of intracranial hemorrhage was achieved through NCCT.

You may qualify if:

• The confirmation of intracranial hemorrhage was achieved through NCCT.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, China

Location

Related Publications (5)

• Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available.

  PMID: 35579034 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

• Liu X, Zhang Q, Li J, Xu Q, Zhuo Z, Li J, Zhou X, Lu M, Zhou Q, Pan H, Wu N, Zhou Q, Shi F, Lu G, Liu Y, Zhang Z. Coordinatized lesion location analysis empowering ROI-based radiomics diagnosis on brain gliomas. Eur Radiol. 2023 Dec;33(12):8776-8787. doi: 10.1007/s00330-023-09871-y. Epub 2023 Jun 29.

  PMID: 37382614 BACKGROUND

• Ding L, Liu H, Jing J, Jiang Y, Meng X, Chen Y, Zhao X, Niu H, Liu T, Wang Y, Li Z. Lesion Network Mapping for Neurological Deficit in Acute Ischemic Stroke. Ann Neurol. 2023 Sep;94(3):572-584. doi: 10.1002/ana.26721. Epub 2023 Jun 27.

  PMID: 37314250 BACKGROUND

• Boe NJ, Hald SM, Jensen MM, Kristensen LMB, Bojsen JA, Elhakim MT, Clausen A, Moller S, Hallas J, Garcia Rodriguez LA, Selim M, Goldstein LB, Al-Shahi Salman R, Gaist D. Major Cardiovascular Events After Spontaneous Intracerebral Hemorrhage by Hematoma Location. JAMA Netw Open. 2023 Apr 3;6(4):e235882. doi: 10.1001/jamanetworkopen.2023.5882.

  PMID: 37017964 BACKGROUND

Study Officials

• Guangming Lu

  Deparetment of Radiology, Jinling Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Medical Imaging Center of the Jinling Hospital

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

CN (1)