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

Primary Purpose

Blood Pressure Variability, Intracranial Artery Stenosis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Amlodipine

ACEI / ARB

Aspirin or Clopidogrel

Atorvastatin

About this trial

This is an interventional treatment trial for Blood Pressure Variability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

RenJi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

amlodipine

ACEI / ARB

Arm Description

The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )

ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)

Outcomes

Primary Outcome Measures

the incidence of stroke in a follow-up period

Secondary Outcome Measures

blood pressure during the compliance status in a follow-up

patients with blood pressure variability in a follow-up

Changes in intracranial arterial stenosis and stiffness before and after the follow-up

Other vascular events ( acute ischemic heart disease or vascular death )

Full Information

NCT ID

NCT01665235

First Posted

August 13, 2012

Last Updated

August 14, 2012

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01665235

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RenJi Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Pressure Variability, Intracranial Artery Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

amlodipine

Arm Type

Active Comparator

Arm Description

The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )

Arm Title

ACEI / ARB

Arm Type

Experimental

Arm Description

ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)

Intervention Type

Drug

Intervention Name(s)

Amlodipine

Intervention Description

The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )

Intervention Type

Drug

Intervention Name(s)

ACEI / ARB

Intervention Description

ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)

Intervention Type

Drug

Intervention Name(s)

Aspirin or Clopidogrel

Intervention Description

aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin 10 - 40mg / d ( statin therapy)

Primary Outcome Measure Information:

Title

the incidence of stroke in a follow-up period

Time Frame

one year

Secondary Outcome Measure Information:

Title

blood pressure during the compliance status in a follow-up

Time Frame

one year

Title

patients with blood pressure variability in a follow-up

Time Frame

one year

Title

Changes in intracranial arterial stenosis and stiffness before and after the follow-up

Time Frame

one year

Title

Other vascular events ( acute ischemic heart disease or vascular death )

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guowen Shi, MD

Phone

86-13651932966

shigw228@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guowen Shi, MD

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

RenJi Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guowen Shi, MD

12. IPD Sharing Statement

Learn more about this trial

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

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