NCT03256513

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

2.1 years

First QC Date

June 1, 2017

Last Update Submit

August 17, 2017

Conditions

Cerebral RevascularizationIschemic Cerebrovascular Disease

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • transient ischemic attack,TIA

    30 days

  • cerebral hemorrhage

    30 days

  • hyperperfusion syndrome

    30 days

  • epilepsy

    30 days

Study Arms (2)

model controlling

EXPERIMENTAL

an statistical model for periprocedural blood pressure control

Other: model controlling

conventional controlling

ACTIVE COMPARATOR

an conventional strategy for periprocedural blood pressure control

Other: conventional controlling

Interventions

model controllingOTHER

control blood pressure by statistical l model with anticipate lowest peri-procedure risk

model controlling
conventional controllingOTHER

control blood pressure by conventional strategy

conventional controlling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurosurgery, Xuanwu hospital

Beijing, 100053, China

RECRUITING

Study Officials

  • Liqun Jiao, MD

    Department of neurosurgery, Xuanwu hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqun Jiao, MD

CONTACT

86-10-83198899jiaoliqun@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical investigator

Study Record Dates

First Submitted

June 1, 2017

First Posted

August 22, 2017

Study Start

April 10, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

CN(1)