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

Blood Pressure Variability Clinical Trial

Official title:

The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01665235
• Other study ID #: RenJiH-20120804
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2012
• Last updated: August 14, 2012
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2012
• Source: RenJi Hospital
• Contact: Guowen Shi, MD
• Phone: 86-13651932966
• Email: shigw228[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure Variability
• Constriction, Pathologic
• Intracranial Artery Stenosis

Intervention

Drug:
• Amlodipine
The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
• ACEI / ARB
ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
• Aspirin or Clopidogrel
aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)
• Atorvastatin
Atorvastatin 10 - 40mg / d ( statin therapy)

Locations

Country	Name	City	State
China	RenJi Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of stroke in a follow-up period		one year	Yes
Secondary	blood pressure during the compliance status in a follow-up		one year	Yes
Secondary	patients with blood pressure variability in a follow-up		one year	Yes
Secondary	Changes in intracranial arterial stenosis and stiffness before and after the follow-up		one year	Yes
Secondary	Other vascular events ( acute ischemic heart disease or vascular death )		one year	Yes