Intracerebral HemorrhageCATCH-AINCT04951570
Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence
An observational study of Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 1,374 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2021to 2 Feb 2023
- How long will I take part?
- 12 Months
- 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: Patients diagnosed with sICH that arrived at hospital within 24 hours.
Who may be able to join
- Diagnosis of spontaneous intracerebral hemorrhage(sICH)
- Age ≥18;
- Admission within 24 hours of symptom onset
- CT available at 24 hours
- Informed consent obtained
Who cannot join
- Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc.
- Deep coma at admission (GCS≤8)
- Intended to have a surgery within 24 hours
- Congenital coagulation dysfunction
- Previous intracerebral hematoma have not been absorbed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial
The purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.
Read the detailed description
This is a investigator-initiated, multi-center, prospective, registered cohort study. The study is intended to enroll 4000 patients with intracerebral hemorrhage from 50 hospital in China. Clinical and imaging data, as well as the results of laboratory examination will be collected to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Hematoma Expansion, Artificial Intelligence
- Medical subject headings
- Cerebral Hemorrhage
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 |
|---|---|---|
| Hematoma Expansion (HE) group | Not described | |
| non-HE group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma expansion
non-contrast CT scan: the enlargement of hematoma ≥6ml
Measured: 24-48 hours from symptom onset
Recurrence of intracerebral hemorrhage
non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma
Measured: 90 days from symptom onset
Functional dependence
modified Rankin Scale score ≥3 (a global measure of disability on a seven-level scale, with scores ranging from 0 (no symptoms) to 6 (death), higher scores mean a better or worse outcome )
Measured: 3 months
Cerebrovascular death
Death due to one of the following events: ischemic stroke or hemorrhagic stroke
Measured: 3 months
Cardiovascular death
Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure
Measured: 3 months
Secondary outcomes (3)
New ischemic stroke
Acute focal neurological impairment corresponding with infarction on CT/MR scan
Measured: 3 months
New subarachnoid hemorrhage
Hemorrhage in subarachnoid space proven on CT/MR scan
Measured: 3 months
Other cardiovascular events
One of the following events: non-fatal myocardial infarction or non-fatal heart failure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start23 Jun 2021
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- 1,374 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingquan Zhao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951570
- Sponsor's protocol ID
- CATCH-AI
- Acronym
- CATCH-AI
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial
- ClinicalTrials.gov ID
- NCT04951570
- Acronym / sponsor ID
- CATCH-AI / CATCH-AI
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Hematoma Expansion, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,374 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 7 Jul 2021 (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 purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.
Detailed description
This is a investigator-initiated, multi-center, prospective, registered cohort study. The study is intended to enroll 4000 patients with intracerebral hemorrhage from 50 hospital in China. Clinical and imaging data, as well as the results of laboratory examination will be collected to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematoma Expansion (HE) group | – | – |
| non-HE group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with sICH that arrived at hospital within 24 hours.
Key inclusion criteria (5 listed)
- Diagnosis of spontaneous intracerebral hemorrhage(sICH)
- Age ≥18;
- Admission within 24 hours of symptom onset
- CT available at 24 hours
- Informed consent obtained
Key exclusion criteria (5 listed)
- Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc.
- Deep coma at admission (GCS≤8)
- Intended to have a surgery within 24 hours
- Congenital coagulation dysfunction
- Previous intracerebral hematoma have not been absorbed
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
hematoma expansion
Time frame: 24-48 hours from symptom onset
non-contrast CT scan: the enlargement of hematoma ≥6ml
Recurrence of intracerebral hemorrhage
Time frame: 90 days from symptom onset
non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma
Functional dependence
Time frame: 3 months
modified Rankin Scale score ≥3 (a global measure of disability on a seven-level scale, with scores ranging from 0 (no symptoms) to 6 (death), higher scores mean a better or worse outcome )
Cerebrovascular death
Time frame: 3 months
Death due to one of the following events: ischemic stroke or hemorrhagic stroke
Cardiovascular death
Time frame: 3 months
Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure
3 secondary outcomes
New ischemic stroke
Time frame: 3 months
New subarachnoid hemorrhage
Time frame: 3 months
Other cardiovascular events
Time frame: 3 months
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 28 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intracerebral Hemorrhage, run by Beijing Tiantan Hospital 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 5 inclusion and 5 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 28 Feb 2023. 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?
hematoma expansion (time frame: 24-48 hours from symptom onset). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.