Study of Collateral Circulation and Related Gene Polymorphism in Patients With Symptomatic Intracranial Anterior Circulation Aortic Occlusion

Study of Collateral Circulation in Patients With Symptomatic Intracranial Anterior Circulation Occlusion

Sponsors

Lead sponsor: The Second Hospital of Hebei Medical University

Source The Second Hospital of Hebei Medical University
Brief Summary

Intracranial artery stenosis is the leading cause of stroke onset or recurrence in Asian. Multiple studies have shown that anterior circulation is most common in intracranial artery stenosis, especially the middle cerebral artery in patients with symptomatic or asymptomatic ischemic stroke. Based on the clinical experiences, we found that the cerebral collateral development can affect clinical symptoms seriously in patients with large artery stenosis. Compensated blood flow can reach the ischemic area through collateral circulation (including circle of Willis, leptomeningeal collaterals, extracranial to intracranial collaterals, and new angiogenesis) when the blood-supplying artery of the brain is severely stenotic or even occluded, however, considerable differences across individuals exist. Studies have shown statins and butylphthalide can promote collateral circulation. The influencing factors on collateral circulation building have not been completely identified yet, but a recent research found that Naturally occurring variants of Rabep2(Rab GTPase binding effector protein 2)are major determinants of variation in collateral extent and stroke severity in mice. On this basis, clinical trials have been conducted in order to confirm that the Rabep2 gene is associated with individual differences in the collateral circulation.

Summarizing new findings, we suspect whether the difference in the degree of collateral circulation is significant for long-term prognosis in patients with cerebral large arterial occlusion, and whether promoting collateral circulation and new angiogenesis can become a new treatment approach. Hereby, we plan to recruit 500 patients with cerebral large-artery occlusion, collect clinical and Imaging (CTA) information, analyze and investigate if the difference in the degree of collateral circulation can be the independent influencing factor for long-term prognosis. This study will collect blood sample of patients and further examine SNPs of Rabep2, and will then analyze the correlation between Rabep2 and patients with cerebral large-artery occlusion. This project will follow up rolled patients for 1 year, observe if long-term intake of butylphthalide can promote cerebral collateral development.

Overall Status Recruiting
Start Date May 5, 2019
Completion Date May 1, 2020
Primary Completion Date January 1, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
collateral circulation level 1 hour
Enrollment 500
Condition
Intervention

Intervention type: Drug

Intervention name: Butylphthalide Soft Capsules

Description: The first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation.

Arm group label: Long-term administration of Butylphthalide Soft Capsules

Other name: NBP

Eligibility

Criteria:

Inclusion Criteria:

1. Patients with arterial occlusion on unilateral or bilateral intracranial segment of internal carotid artery and/or middle cerebral artery were diagnosed by CTA; 2 complete medical records;

Exclusion Criteria:

1. CTA showed no arterial occlusion on unilateral or bilateral intracranial segment of internal carotid artery and/or middle cerebral artery; 2. Follow-up interventional surgery; 3. Death within 30 days of onset; 4. Clinical data incomplete; 5. Loss of follow-up patient.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Xiaoyun Liu, Prf. Principal Investigator The Second Hospital of Hebei Medical University
Overall Contact

Last name: Kun Zhang, Dr.

Phone: +8618633922056

Email: [email protected]

Location
facility status contact Second hospital of hebei medical university Xiaoyun Liu, Prf. +8613191887318 [email protected]
Location Countries

China

Verification Date

September 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: The Second Hospital of Hebei Medical University

Investigator full name: liuxiaoyun

Investigator title: Deputy Director of Neurology Department

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Long-term administration of Butylphthalide Soft Capsules

Arm group type: Experimental

Description: In addition to standard secondary preventive drugs, such as atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets, patients in this group take Butylphthalide Soft Capsules orally, 0.2g per serving, three times a day for one year.

Arm group label: Standard secondary prevention group

Arm group type: No Intervention

Description: patients in this group take atorvastatin calcium tablets, aspirin enteric-coated tablets and/or clopidogrel hydrogen sulphate tablets as standard secondary prevention.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov