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The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization

Primary Purpose

Cerebral Revascularization, Ischemic Cerebrovascular Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
model controlling
conventional controlling
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Revascularization

Eligibility Criteria

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

Inclusion Criteria:

  • symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA;
  • without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI;
  • informed consent acquired.

Exclusion Criteria:

  • lesion beyond range limit of procedure (higher than C2);
  • target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure
  • nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation;
  • history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia;
  • history of severe injury, surgery or radiotherapy on neck;
  • with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation;
  • with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion;
  • with other comorbidity, expected life < 2 years;
  • severe diabetes mellitus difficult to control, blood sugar >300mg/dl;
  • pregnancy or peri-natal period;
  • intolerance to systematic anesthesia or surgery after adequate preparation.
  • intolerance to peri-procedural drug possible to administrated;
  • not cooperating or rejecting to informed consent;

Sites / Locations

  • Department of neurosurgery, Xuanwu hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

model controlling

conventional controlling

Arm Description

an statistical model for periprocedural blood pressure control

an conventional strategy for periprocedural blood pressure control

Outcomes

Primary Outcome Measures

death
all cause death
ischemic stroke
Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.
cardiovascular events
Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.

Secondary Outcome Measures

transient ischemic attack,TIA
transient ischemic attack, TIA is defined as: Patients with new onset of neurological symptoms and / or signs, duration < 24 hours, MRI diffusion weighted imaging (DWI) did not find new infarcts. If MRI DWI showed new lesion, ischemic stroke was defined.
cerebral hemorrhage
cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.
hyperperfusion syndrome
Hyperfusion Syndrome is defined as : 30 days after operation, new onset headache, vomiting, mental symptoms, macular edema, focal seizures, neurological dysfunction, or imaging brain edema, visible bleeding, and exception of new ischemic cerebral infarction or other causes.
epilepsy
epilepsy is defined as focal onset, with or without evolution to a bilateral tonic-clonic seizure, confirmed by EEG findings including interictal epileptiform discharges (IEDs), lateralized periodic discharges (LPDs; previously known as periodic lateralized epileptiform discharges [PLEDs]), and generalized periodic discharges (GPDs)

Full Information

First Posted
June 1, 2017
Last Updated
August 17, 2017
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Tiantan Hospital, Peking University Third Hospital, The 306 Hospital of People's Liberation Army
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1. Study Identification

Unique Protocol Identification Number
NCT03256513
Brief Title
The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization
Official Title
The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Tiantan Hospital, Peking University Third Hospital, The 306 Hospital of People's Liberation Army

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Revascularization, Ischemic Cerebrovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
model controlling
Arm Type
Experimental
Arm Description
an statistical model for periprocedural blood pressure control
Arm Title
conventional controlling
Arm Type
Active Comparator
Arm Description
an conventional strategy for periprocedural blood pressure control
Intervention Type
Other
Intervention Name(s)
model controlling
Intervention Description
control blood pressure by statistical l model with anticipate lowest peri-procedure risk
Intervention Type
Other
Intervention Name(s)
conventional controlling
Intervention Description
control blood pressure by conventional strategy
Primary Outcome Measure Information:
Title
death
Description
all cause death
Time Frame
30 days
Title
ischemic stroke
Description
Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging.
Time Frame
30 days
Title
cardiovascular events
Description
Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
transient ischemic attack,TIA
Description
transient ischemic attack, TIA is defined as: Patients with new onset of neurological symptoms and / or signs, duration < 24 hours, MRI diffusion weighted imaging (DWI) did not find new infarcts. If MRI DWI showed new lesion, ischemic stroke was defined.
Time Frame
30 days
Title
cerebral hemorrhage
Description
cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.
Time Frame
30 days
Title
hyperperfusion syndrome
Description
Hyperfusion Syndrome is defined as : 30 days after operation, new onset headache, vomiting, mental symptoms, macular edema, focal seizures, neurological dysfunction, or imaging brain edema, visible bleeding, and exception of new ischemic cerebral infarction or other causes.
Time Frame
30 days
Title
epilepsy
Description
epilepsy is defined as focal onset, with or without evolution to a bilateral tonic-clonic seizure, confirmed by EEG findings including interictal epileptiform discharges (IEDs), lateralized periodic discharges (LPDs; previously known as periodic lateralized epileptiform discharges [PLEDs]), and generalized periodic discharges (GPDs)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA; without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI; informed consent acquired. Exclusion Criteria: lesion beyond range limit of procedure (higher than C2); target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation; history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia; history of severe injury, surgery or radiotherapy on neck; with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation; with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion; with other comorbidity, expected life < 2 years; severe diabetes mellitus difficult to control, blood sugar >300mg/dl; pregnancy or peri-natal period; intolerance to systematic anesthesia or surgery after adequate preparation. intolerance to peri-procedural drug possible to administrated; not cooperating or rejecting to informed consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liqun Jiao, MD
Phone
86-10-83198899
Ext
8836
Email
jiaoliqun@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, MD
Organizational Affiliation
Department of neurosurgery, Xuanwu hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of neurosurgery, Xuanwu hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, MD
Phone
86-10-83198899
Ext
8836
Email
jiaoliqun@gmail.com

12. IPD Sharing Statement

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The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization

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