Spontaneous Intracerebral HemorrhageNCT06498778
Etiology and Prognosis of sICH Based on Hemorrhage Location
An observational study of Spontaneous Intracerebral Hemorrhage, run by Jinling Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage
- How many people
- 698 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: This retrospective study encompassed the collection of sICH patients. The confirmation of intracranial hemorrhage was achieved through NCCT.
Who may be able to join
- The confirmation of intracranial hemorrhage was achieved through NCCT.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- Normative analysis; Lesion-symptom mapping; Radiomics; Etiological classification; Machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) scores
Good outcome as "mRS = 0-2", poor outcome as "mRS = 3-6"
Measured: follow-ups at twelve months post sICH event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jul 2021
- Primary completion31 Dec 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangming Lu, Jinling Hospital, China
- Investigators
- Guangming Lu, Study director, Deparetment of Radiology, Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498778
- Sponsor's protocol ID
- 2022DZGZR-074
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35579034Winstein 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.
PubMed 27145936Liu 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.
PubMed 37382614Ding 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.
PubMed 37314250Boe 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.
PubMed 37017964
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Etiology and Prognosis Based on Hematoma Location of Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06498778
- Acronym / sponsor ID
- 2022DZGZR-074
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- Normative analysis; Lesion-symptom mapping; Radiomics; Etiological classification; Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This retrospective study encompassed the collection of sICH patients. The confirmation of intracranial hemorrhage was achieved through NCCT.
Key inclusion criteria (1 listed)
- The confirmation of intracranial hemorrhage was achieved through NCCT.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 35579034Greenberg 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.
- Background: PubMed 27145936Winstein 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.
- Background: PubMed 37382614Liu 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.
- Background: PubMed 37314250Ding 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.
- Background: PubMed 37017964Boe 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.
- Individual participant dataSharing planned: Undecided
Related trials for Spontaneous Intracerebral Hemorrhage
Recruiting
PREcision MApping and NEuromodulation After Spontaneous Intracerebral Hemorrhage: The PREMANE Trial
Spontaneous Intracerebral Hemorrhage
Not yet recruiting
Haptic-Assisted Virtual Reality Upper-Limb Rehabilitation After Intracerebral Haemorrhage
Intracerebral Hemorrhage, Hemorrhagic Stroke
Not yet recruitingObservational study
Outcome Prediction and Recovery After Spontaneous Intracerebral Haemorrhage
Intracerebral Hemorrhage, Hemorrhagic Stroke
Not yet recruiting
REmifentanil And Dexmedetomidine for EarlY Intensive Blood Pressure Lowering in ICH.
Intracerebral Hemorrhage
Not yet recruitingObservational study
Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangming Lu study director
Deparetment of Radiology, Jinling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Intracerebral Hemorrhage, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) scores (time frame: follow-ups at twelve months post sICH event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06498778, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.