Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA) (ChTUIA)

The goal of this prospective observational cohort study is to learn about treatment strategies for unruptured intracranial aneurysms in the Chinese population. The main questions it aims to answer are:

• To establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy.
• To establish clinical management path for patients with unruptured intracranial aneurysm.

According to the treatment of all patients with unruptured intracranial aneurysm, they were divided into the following groups: 1. Conservative treatment group; 2. Intracranial aneurysm clipping group; 3. Coil embolization or stent-assisted coil embolization group; 4. Flow diversion group.

Study Overview

• Status: Recruiting
• Conditions: Unruptured Intracranial Aneurysm
• Intervention / Treatment: Other: observation

• Study Type: Observational
• Enrollment (Anticipated): 21041

Contacts and Locations

• Study Contact: Name: Wang shuo, M.D.; Phone Number: +86 13801180330; Email: captain9858@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Capital Medical University Affiliated Beijing Tiantan Hospital
      • Contact: JUN WU, MD; Phone Number: +8613426322945; Email: wujunslf@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with unruptured intracranial aneurysm

Description

Inclusion Criteria:

A. age > 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.

Exclusion Criteria:

1. Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;
2. Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;
3. Combined with cerebrovascular malformations ;
4. Combined with brain tumors or malignant tumors in other parts ;
5. with acute myocardial infarction ;
6. in acute or chronic heart failure ( New York Heart Association classification > 2 points ) ;
7. combined with systemic connective tissue disease and systemic rheumatic disease ;
8. Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;
9. during pregnancy and perinatal period

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conservative treatment group; Patients in conservative treatment group receive optimal drug therapy including appropriate blood pressure control and other measures.	Other: observation; observation
Intracranial aneurysm clipping group; Patients in Intracranial aneurysm clipping group receive neurosurgical clipping.	Other: observation; observation
Coil embolization or stent-assisted coil embolization group; Patients in coil embolization or stent-assisted coil embolization group receive coil embolization or stent-assisted coil embolization according to individualized condition.	Other: observation; observation
Flow diversion group.; Patients in flow diversion group receive flow diverters.	Other: observation; observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Functional outcomes(modified Rankin Scale,mRS) at 2 years after treatment decision	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE events	Incidence of major adverse cardiovascular/cerebrovascular events (MACCE events) in patients with atherosclerotic heart disease within 1 year after treatment decision.	1 years
cardiovascular/cerebrovascular events	Incidence of cardiovascular/cerebrovascular events in 2 years after receiving different treatment strategies.	2 years
Cost	Costs associated with unruptured intracranial aneurysms within 2 years after treatment with different strategies.	2 years
Aneurysm-related bleeding events	Incidence of aneurysmal-related bleeding events within 2 years after receiving different treatment strategies.	2 years
Mortality associated with intracranial aneurysms	Mortality associated with intracranial aneurysms within 2 years after treatment with different strategies	2 years
All-cause mortality	All-cause mortality of patients within 2 years after different treatment strategies.	2 years

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Huashan Hospital; First Affiliated Hospital of Fujian Medical University; The First Affiliated Hospital of Zhengzhou University; Shanxi Provincial People's Hospital
• Investigators: Study Chair: Wang shuo, M.D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: KY2022-226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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