Etiology and Prognosis of sICH Based on Hemorrhage Location

July 6, 2024 updated by: Guangming Lu, Jinling Hospital, China

Prediction of Etiology and Prognosis Based on Hematoma Location of Spontaneous Intracerebral Hemorrhage

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

698

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS) scores
Time Frame: follow-ups at twelve months post sICH event
Good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6"
follow-ups at twelve months post sICH event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Study Director: Guangming Lu, Deparetment of Radiology, Jinling Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

July 6, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 6, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022DZGZR-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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