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

Sponsor

Liu Zhiyong (Other)

Overall Status

Unknown status

CT.gov ID

NCT03153878

Collaborator

Xuanwu Hospital, Beijing (Other)

1,800

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm Natural History Ischemic Heart Disease Ischemic Cerebrovascular Disease

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

Acute myocardial infarction [Up to 4 years]]
Acute myocardial infarction
New onset ischemic stroke [Up to 4 years]]
New onset ischemic stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA);
Patient with premorbid mRS of 3 or less;
Patient older than 14years;
Patient consenting to participate to the study;
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