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

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

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

Study Overview

• Status: Unknown
• Conditions: Intracranial Artery Stenosis; Blood Pressure Variability
• Intervention / Treatment: Drug: Amlodipine; Drug: Aspirin or Clopidogrel; Drug: Atorvastatin; Drug: ACEI / ARB

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guowen Shi, MD; Phone Number: 86-13651932966; Email: shigw228@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital
      • Principal Investigator: Guowen Shi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence of stroke in a follow-up period	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Guowen Shi, MD, RenJi Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ANTICIPATED): August 1, 2014
• Study Completion (ANTICIPATED): August 1, 2014

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (ESTIMATE): August 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Stroke; Ischemic Stroke; Constriction, Pathologic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Aspirin; Atorvastatin; Clopidogrel; Amlodipine
• Other Study ID Numbers: RenJiH-20120804