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

Not Applicable

• Conditions: Ischemic Cerebrovascular Disease; Cerebral Revascularization
• Interventions: Other: model controlling; Other: conventional controlling

• Registration Number: NCT03256513
• Lead Sponsor: Xuanwu Hospital, Beijing

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-06-01
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Study First Posted: 2017-08-22
• Last Update Posted: 2017-08-22
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
model controlling	model controlling	an statistical model for periprocedural blood pressure control
conventional controlling	conventional controlling	an conventional strategy for periprocedural blood pressure control

Primary Outcome Measures

Name	Time	Method
death	30 days	all cause death
cardiovascular events	30 days	Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.
ischemic stroke	30 days	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.

Secondary Outcome Measures

Name	Time	Method
transient ischemic attack,TIA	30 days	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.
hyperperfusion syndrome	30 days	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.
cerebral hemorrhage	30 days	cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.
epilepsy	30 days	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)

Trial Locations

Locations (1)

Department of neurosurgery, Xuanwu hospital; 🇨🇳 Beijing, China