Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

Not Applicable

• Conditions: Blood Pressure Variability; Intracranial Artery Stenosis
• Interventions: Drug: Amlodipine; Drug: ACEI / ARB; Drug: Aspirin or Clopidogrel; Drug: Atorvastatin

• Registration Number: NCT01665235
• Lead Sponsor: RenJi Hospital

Brief Summary

Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis

Detailed Description

Extracranial atherosclerotic stenosis is the main reason for the European and American white ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51% of a etiology ratio.The latest research suggests that varying degrees of blood pressure variability can affect the risk of stroke.This study observe the relationship between blood pressure variability and prognosis of ischemic stroke patients with intracranial arterial stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography and Trans-cranial Doppler(TCD) .

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age : ≥ 18 years of age , ≤ 75 years old
• with intracranial artery stenosis in ischemic stroke
• the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic criteria developed by the Chinese Medical Association Fourth National Cerebrovascular Disease Conference
• the patient admitted to hospital receive at least one examination like cranial MRI + DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis
• MRS score ≤ 3 points

Exclusion Criteria

• vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke
• associated with significant emotional disorders, cognitive impairment or other mental disorders can not be partners
• severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral stenosis more than 70%
• With extracranial artery stenosis, especially carotid and vertebral artery stenosis .
• patients with extracranial artery stenosis or patients previously done neck or intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy
• Incomplete clinical data collection in patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
amlodipine	Amlodipine	The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
amlodipine	Aspirin or Clopidogrel	The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
amlodipine	Atorvastatin	The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
ACEI / ARB	ACEI / ARB	ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
ACEI / ARB	Aspirin or Clopidogrel	ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
ACEI / ARB	Atorvastatin	ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)

Primary Outcome Measures

Name	Time	Method
the incidence of stroke in a follow-up period	one year

Secondary Outcome Measures

Name	Time	Method
blood pressure during the compliance status in a follow-up	one year
patients with blood pressure variability in a follow-up	one year
Changes in intracranial arterial stenosis and stiffness before and after the follow-up	one year
Other vascular events ( acute ischemic heart disease or vascular death )	one year

Trial Locations

Locations (1)

RenJi Hospital; 🇨🇳 Shanghai, Shanghai, China