Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence (CATCH-AI)

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.

Study Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage

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 Type: Observational
• Enrollment (Actual): 1374

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with sICH that arrived at hospital within 24 hours.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hematoma Expansion (HE) group
non-HE group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematoma expansion	non-contrast CT scan: the enlargement of hematoma ≥6ml	24-48 hours from symptom onset
Recurrence of intracerebral hemorrhage	non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma	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 )	3 months
Cerebrovascular death	Death due to one of the following events: ischemic stroke or hemorrhagic stroke	3 months
Cardiovascular death	Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New ischemic stroke	Acute focal neurological impairment corresponding with infarction on CT/MR scan	3 months
New subarachnoid hemorrhage	Hemorrhage in subarachnoid space proven on CT/MR scan	3 months
Other cardiovascular events	One of the following events: non-fatal myocardial infarction or non-fatal heart failure	3 months

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Intracerebral Hemorrhage; Hematoma Expansion
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: CATCH-AI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No