Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

NCT04951570 | Completed

• 1 other identifier: CATCH-AI
• Study Type: observational
• Target: 1,374
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Hematoma Expansion; Artificial Intelligence

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• New ischemic stroke

  3 months

• New subarachnoid hemorrhage

  3 months

• Other cardiovascular events

  3 months

Study Arms (2)

Hematoma Expansion (HE) group

non-HE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of spontaneous intracerebral hemorrhage(sICH)
• Age ≥18;
• Admission within 24 hours of symptom onset
• CT available at 24 hours
• Informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples and urine samples

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Stroke Center

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 7, 2021
• Study Start: June 23, 2021
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)