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

Liu Zhiyong

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03153878

2016YFC1300803

Details and patient eligibility

About

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

Full 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

Enrollment: 1,800 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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