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

Ischemic Cerebrovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03256513
• Other study ID #: D161100003816002
• Status: Recruiting
• Phase: N/A
• First received: June 1, 2017
• Last updated: August 17, 2017
• Start date: April 10, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2017
• Source: Xuanwu Hospital, Beijing
• Contact: Liqun Jiao, MD
• Phone: 86-10-83198899
• Email: jiaoliqun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2270
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cerebral Revascularization
• Cerebrovascular Disorders
• Ischemia
• Ischemic Cerebrovascular Disease

Intervention

Other:
• model controlling
control blood pressure by statistical l model with anticipate lowest peri-procedure risk
• conventional controlling
control blood pressure by conventional strategy

Locations

Country	Name	City	State
China	Department of neurosurgery, Xuanwu hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Beijing Tiantan Hospital, Peking University Third Hospital, The 306 Hospital of People's Liberation Army

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	all cause death	30 days
Primary	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
Primary	cardiovascular events	Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.	30 days
Secondary	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
Secondary	cerebral hemorrhage	cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.	30 days
Secondary	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
Secondary	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