Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

Intracerebral Hemorrhage Clinical Trial

— CATCH-AI  

Official title:

Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951570
• Other study ID #: CATCH-AI
• Status: Completed
• Start date: June 23, 2021
• Est. completion date: February 2, 2023

Study information

• Verified date: February 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1374
• Est. completion date: February 2, 2023
• Est. primary completion date: February 2, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)

2. Age =18;

3. Admission within 24 hours of symptom onset

4. CT available at 24 hours

5. Informed consent obtained

Exclusion Criteria:

1. Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc.

2. Deep coma at admission (GCS=8)

3. Intended to have a surgery within 24 hours

4. Congenital coagulation dysfunction

5. Previous intracerebral hematoma have not been absorbed

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematoma expansion	non-contrast CT scan: the enlargement of hematoma =6ml	24-48 hours from symptom onset
Primary	Recurrence of intracerebral hemorrhage	non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma	90 days from symptom onset
Primary	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 )	3 months
Primary	Cerebrovascular death	Death due to one of the following events: ischemic stroke or hemorrhagic stroke	3 months
Primary	Cardiovascular death	Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure	3 months
Secondary	New ischemic stroke	Acute focal neurological impairment corresponding with infarction on CT/MR scan	3 months
Secondary	New subarachnoid hemorrhage	Hemorrhage in subarachnoid space proven on CT/MR scan	3 months
Secondary	Other cardiovascular events	One of the following events: non-fatal myocardial infarction or non-fatal heart failure	3 months