Cerebral HemorrhageNCT05424614
Study on the Prognostic Prediction Model of Patients With Acute Intracerebral Hemorrhage by Artificial Intelligence
An observational study of Cerebral Hemorrhage and Prognosis, run by Beijing Neurosurgical Institute at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Hemorrhage, Prognosis, Artificial Intelligence
- What is being tested?
- Functional outcome follow-up of patients
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2022to 30 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute cerebral hemorrhage (within 6 hours of the onset of symptoms) who presented to the hospital between May 2022 and September 2024 and had complete medical records.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Capital's Funds for Health Improvement and Research
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.
- Conditions
- Cerebral Hemorrhage, Prognosis, Artificial Intelligence
- Being tested
- Functional outcome follow-up of patients
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional outcome follow-up of patientsOther
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
| Study group | Role | What they receive |
|---|---|---|
| intracerebral hemorrhage group | Patients with the intracerebral hemorrhage who presented to the hospital within 24 hours of symptom onset Receives: Other: Functional outcome follow-up of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient outcome
Neurological recovery status was measured by the modified Rankin Scale
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start13 May 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebral 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shengjun Sun, Principal investigator, Beijing Neurosurgical Instuitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424614
- Sponsor's protocol ID
- 2022-2-1074
- Status last verified
- May 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To obtain individual participant data, please contact the principal investigator.
Publications
Pszczolkowski S, Manzano-Patron 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.
PubMed 33860831Xie 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.
PubMed 31385050Guo 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):112. doi: 10.3390/jpm12010112.
PubMed 35055424Gregorio T, Pipa S, Cavaleiro P, Atanasio 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.
PubMed 30458727Fu 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.
PubMed 30354984Wang 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.
PubMed 33123072Menon 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.
PubMed 33183885Morotti 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.
PubMed 32847959Tseng 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.
PubMed 33743639
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capital's Funds for Health Improvement and Research
- ClinicalTrials.gov ID
- NCT05424614
- Acronym / sponsor ID
- 2022-2-1074
- Conditions
- Cerebral Hemorrhage, Prognosis, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Jun 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intracerebral hemorrhage group | – | Other: Functional outcome follow-up of patientsPatients with the intracerebral hemorrhage who presented to the hospital within 24 hours of symptom onset |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute cerebral hemorrhage (within 6 hours of the onset of symptoms) who presented to the hospital between May 2022 and September 2024 and had complete medical records.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional outcome follow-up of patientsPatients 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 | Other | intracerebral hemorrhage group |
Primary outcome
patient outcome
Time frame: 3 month
Neurological recovery status was measured by the modified Rankin Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Background: PubMed 33860831Pszczolkowski S, Manzano-Patron 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.
- Background: PubMed 31385050Xie 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.
- Background: PubMed 35055424Guo 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):112. doi: 10.3390/jpm12010112.
- Background: PubMed 30458727Gregorio T, Pipa S, Cavaleiro P, Atanasio 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.
- Background: PubMed 30354984Fu 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.
- Background: PubMed 33123072Wang 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.
- Background: PubMed 33183885Menon 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.
- Background: PubMed 32847959Morotti 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.
- Background: PubMed 33743639Tseng 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.
- Individual participant dataSharing planned: Undecided. To obtain individual participant data, please contact the principal investigator.
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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.
Shengjun Sun principal investigator
Beijing Neurosurgical Instuitute
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 Cerebral Hemorrhage and Prognosis, run by Beijing Neurosurgical Institute 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 1 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengjun Sun (13611293369, sunshengjun0212@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient outcome (time frame: 3 month). 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 NCT05424614, which also lists 9 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 21 Jun 2022.