The Prospective Cohort Study on the Benefit-risk of Antithrombotic or Anticoagulant Therapy in Patients With Unruptured Intracranial Aneurysms Associated With Ischemic Heart Disease or Ischemic Cerebrovascular Disease

• Conditions: Ischemic Heart Disease; Intracranial Aneurysm; Natural History; Ischemic Cerebrovascular Disease

• Registration Number: NCT03153878
• Lead Sponsor: Liu Zhiyong

Brief Summary

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA

Detailed Description

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA. This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China.

During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year. Research data will represent the real natural course of UIA in China. For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Last Update Submitted: 2017-05-11
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15
• Study Start: 2017-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1. Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA);
2. Patient with premorbid mRS of 3 or less;
3. Patient older than 14years;
4. Patient consenting to participate to the study;
5. Patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention

Exclusion Criteria

Subarachnoid hemorrhage with unknown causes;

• Page 4 of 4 [DRAFT] - 2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas; 3. Patient with malignant tumor; 4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related; 5. Inability to obtain informed consent; 6. Patients with a life expectancy less than 1 year; 7. Participating in the other clinical studies of intracranial aneurysm; 8. Refusal of follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aneurysm rupture	Up to 4 years or time of aneurysm repair surgery	Aneurysm rupture
Morphological changes of aneurysms	Up to 4 years or time of aneurysm repair surgery	maximum diameter increase ≥ 1mm or appearance of a daughter sac

Secondary Outcome Measures

Name	Time	Method
Acute myocardial infarction	Up to 4 years]	Acute myocardial infarction
New onset ischemic stroke	Up to 4 years]	New onset ischemic stroke