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

The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease

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 .

Study Overview

• Status: Unknown
• Conditions: Cerebral Revascularization; Ischemic Cerebrovascular Disease
• Intervention / Treatment: Other: model controlling; Other: conventional controlling

• Study Type: Interventional
• Enrollment (Anticipated): 2270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Department of Neurosurgery, Xuanwu hospital
    • Contact: Liqun Jiao, MD; Phone Number: 8836 86-10-83198899; Email: jiaoliqun@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: model controlling; an statistical model for periprocedural blood pressure control	Other: model controlling; control blood pressure by statistical l model with anticipate lowest peri-procedure risk
Active Comparator: conventional controlling; an conventional strategy for periprocedural blood pressure control	Other: conventional controlling; control blood pressure by conventional strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	all cause death	30 days
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.	30 days
cardiovascular events	Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
cerebral hemorrhage	cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.	30 days
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.	30 days
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)	30 days

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Beijing Tiantan Hospital; Peking University Third Hospital; The 306 Hospital of People's Liberation Army
• Investigators: Principal Investigator: Liqun Jiao, MD, Department of Neurosurgery, Xuanwu hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: D161100003816002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No