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Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)

Key facts

Who runs it
Beijing Tiantan Hospital
Where
China1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
3,740 people enrolled
Started
30 Oct 2022
Ended
10 Nov 2024
Type of study
Observational, 2 groups
Treatments tested
  • Obervation
Record updated
3 April 2025

Who can take part

Age
18 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 18-75 years old
  • At least one unruptured intracranial aneurysm was found by CTA
  • No relevant symptoms, receiving non-operative and conservative observation treatment
  • Signing the informed consent

Who cannot take part

  • Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors
  • Suffering from systemic connective tissue diseases, such as polycystic kidney disease
  • Expectant survival of no more than 3 years due to other diseases or poor general conditions
  • Patients refuse to follow up or cannot communicate with them due to mental diseases
  • Fusiform or dissecting aneurysms
  • Traumatic, mycotic and atrial myxoma associated aneurysms
  • Pregnant women or participating in other aneurysm related studies

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Intracranial aneurysm is the main cause of subarachnoid hemorrhage, and the incidence of subarachnoid hemorrhage in Chinese population is about 5%. The intervention of unruptured intracranial aneurysms is controversial because of its great harm after natural rupture and bleeding, and about a quarter of patients still have poor prognosis through existing invasive treatment methods. How to accurately determine the instability risk of unruptured intracranial aneurysms is the key to resolve this controversy.

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In previous studies, the stability of intracranial aneurysms involves many characteristics, and the sample size is small. Most of them are retrospective studies and studies on the status after change (rupture/growth). Therefore, the relevant risk factors are not clear at present, and there is still a lack of reliable prediction model. Based on the above facts, this study proposed based on the national hundred regional medical institutions set up the network registration platform of unruptured intracranial aneurysms, real time and openness of Internet, through the way of case resource sharing build unruptured intracranial aneurysm queue, collecting clinical characteristics, imaging features, hemodynamic detection of biological samples and the results of the analysis data, And observe them for two years. The artificial intelligence platform of Tonglian Medical Health was used to integrate and analyze and learn all the data, and then the risk factors related to the stability of intracranial aneurysms within two years were obtained, and the stability prediction model of unruptured intracranial aneurysms was constructed. This study will build the largest network registration platform and population follow-up cohort of unruptured intracranial aneurysms in China, and put forward a prediction model for the stability of unruptured intracranial aneurysms by integrating the multi-dimensional factors of intracranial aneurysms, so as to provide a powerful auxiliary judgment tool for the clinical decision-making of this disease.

The 2 groups in the trial

  • unstable intracranial aneurysms

    Unstable intracranial aneurysms are defined as the intracranial aneurysms that grows or ruptures.

    Treatment: Obervation

  • stable intracranial aneurysms

    Stable intracranial aneurysms are defined as the intracranial aneurysms that have no significant morphological changes.

    Treatment: Obervation

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
3 April 2025