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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by RenJi Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shi Guowen, RenJi Hospital
ClinicalTrials.gov Identifier:
NCT01665235
First received: August 13, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Blood Pressure Variability
Intracranial Artery Stenosis
Drug: Amlodipine
Drug: ACEI / ARB
Drug: Aspirin or Clopidogrel
Drug: Atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis

Resource links provided by NLM:


Further study details as provided by RenJi Hospital:

Primary Outcome Measures:
  • the incidence of stroke in a follow-up period [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • blood pressure during the compliance status in a follow-up [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • patients with blood pressure variability in a follow-up [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Changes in intracranial arterial stenosis and stiffness before and after the follow-up [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Other vascular events ( acute ischemic heart disease or vascular death ) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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)

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) .

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665235

Contacts
Contact: Guowen Shi, MD 86-13651932966 shigw228@126.com

Locations
China, Shanghai
RenJi Hospital Recruiting
Shanghai, Shanghai, China, 200127
Principal Investigator: Guowen Shi, MD         
Sponsors and Collaborators
RenJi Hospital
Investigators
Principal Investigator: Guowen Shi, MD RenJi Hospital
  More Information

No publications provided

Responsible Party: Shi Guowen, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier: NCT01665235     History of Changes
Other Study ID Numbers: RenJiH-20120804
Study First Received: August 13, 2012
Last Updated: August 14, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Constriction, Pathologic
Pathological Conditions, Anatomical
Aspirin
Clopidogrel
Amlodipine
Atorvastatin
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Protease Inhibitors
Calcium Channel Blockers

ClinicalTrials.gov processed this record on August 21, 2014