Skip to main content
OpenTrials
Completed

NCT Number: NCT04951570

Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. hematoma expansion

    Time frame: 24-48 hours from symptom onset

    non-contrast CT scan: the enlargement of hematoma ≥6ml

  2. Recurrence of intracerebral hemorrhage

    Time frame: 90 days from symptom onset

    non-contrast CT scan: non-traumatic intracerebral hemorrhage other than the primary hemotoma

  3. 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 )

  4. Cerebrovascular death

    Time frame: 3 months

    Death due to one of the following events: ischemic stroke or hemorrhagic stroke

  5. Cardiovascular death

    Time frame: 3 months

    Death due to one of the following events: sudden cardiac death or acute myocardial infarction or heart failure

Secondary outcomes

  1. New ischemic stroke

    Time frame: 3 months

    Acute focal neurological impairment corresponding with infarction on CT/MR scan

  2. New subarachnoid hemorrhage

    Time frame: 3 months

    Hemorrhage in subarachnoid space proven on CT/MR scan

  3. Other cardiovascular events

    Time frame: 3 months

    One of the following events: non-fatal myocardial infarction or non-fatal heart failure

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial

Acronym: CATCH-AI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.