Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)
Study Details
Study Description
Brief Summary
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:
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To establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Primary Outcome [2 years]
Functional outcomes(modified Rankin Scale,mRS) at 2 years after treatment decision
Secondary Outcome Measures
- MACCE events [1 years]
Incidence of major adverse cardiovascular/cerebrovascular events (MACCE events) in patients with atherosclerotic heart disease within 1 year after treatment decision.
- cardiovascular/cerebrovascular events [2 years]
Incidence of cardiovascular/cerebrovascular events in 2 years after receiving different treatment strategies.
- Cost [2 years]
Costs associated with unruptured intracranial aneurysms within 2 years after treatment with different strategies.
- Aneurysm-related bleeding events [2 years]
Incidence of aneurysmal-related bleeding events within 2 years after receiving different treatment strategies.
- Mortality associated with intracranial aneurysms [2 years]
Mortality associated with intracranial aneurysms within 2 years after treatment with different strategies
- All-cause mortality [2 years]
All-cause mortality of patients within 2 years after different treatment strategies.
Eligibility Criteria
Criteria
Inclusion Criteria:
- age > 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.
Exclusion Criteria:
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Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;
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Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;
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Combined with cerebrovascular malformations ;
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Combined with brain tumors or malignant tumors in other parts ;
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with acute myocardial infarction ;
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in acute or chronic heart failure ( New York Heart Association classification > 2 points ) ;
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combined with systemic connective tissue disease and systemic rheumatic disease ;
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Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;
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during pregnancy and perinatal period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Capital Medical University Affiliated Beijing Tiantan Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Beijing Tiantan Hospital
- Huashan Hospital
- The First Affiliated Hospital of Zhengzhou University
- First Affiliated Hospital of Fujian Medical University
- Shanxi Provincial People's Hospital
Investigators
- Study Chair: Wang shuo, M.D., Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY2022-226