The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization
Study Details
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- death [30 days]
all cause 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.
- cardiovascular events [30 days]
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 [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.
- cerebral hemorrhage [30 days]
cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.
- 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.
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA;
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without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI;
-
informed consent acquired.
Exclusion Criteria:
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lesion beyond range limit of procedure (higher than C2);
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target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure
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nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation;
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history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia;
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history of severe injury, surgery or radiotherapy on neck;
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with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation;
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with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion;
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with other comorbidity, expected life < 2 years;
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severe diabetes mellitus difficult to control, blood sugar >300mg/dl;
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pregnancy or peri-natal period;
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intolerance to systematic anesthesia or surgery after adequate preparation.
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intolerance to peri-procedural drug possible to administrated;
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not cooperating or rejecting to informed consent;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of neurosurgery, Xuanwu hospital | Beijing | China | 100053 |
Sponsors and Collaborators
- Xuanwu Hospital, Beijing
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- D161100003816002