CClinicalTrials.gg
Status unknownNCT03256513Updated Aug 22, 2017

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

An interventional study of model controlling and conventional controlling in Cerebral Revascularization and Ischemic Cerebrovascular Disease, sponsored by Xuanwu Hospital, Beijing. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,270
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 .

02

Conditions studied

  • Cerebral Revascularization
  • Ischemic Cerebrovascular Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2,270 participants (estimated)

Study arms

  • Experimental
    model controlling

    an statistical model for periprocedural blood pressure control

    Other: model controlling

  • Active comparator
    conventional controlling

    an conventional strategy for periprocedural blood pressure control

    Other: conventional controlling

Interventions

  • Othermodel controlling

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

  • Otherconventional controlling

    control blood pressure by conventional strategy

05

What researchers measure

Primary outcomes

  1. death

    all cause death

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

  3. cardiovascular events

    Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death.

    Time frame: 30 days

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. cerebral hemorrhage

    cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage.

    Time frame: 30 days

  3. 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.

    Time frame: 30 days

  4. 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)

    Time frame: 30 days

06

Study locations

1 of 1 sites recruiting
  • Department of neurosurgery, Xuanwu hospital
    Beijing, 100053, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03256513
Lead sponsor
Xuanwu Hospital, Beijing
Collaborators
Beijing Tiantan Hospital, Peking University Third Hospital, The 306 Hospital of People's Liberation Army
Responsible party
lingfeng (clinical investigator, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Aug 22, 2017
Start date
Apr 10, 2017
Primary completion
Jun 1, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Aug 22, 2017

Study contacts

Liqun Jiao, MD
Contact
jiaoliqun@gmail.com
86-10-83198899 ext. 8836
Liqun Jiao, MD
principal investigator · Department of neurosurgery, Xuanwu hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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