Blood Pressure Clinical Trial
Official title:
Velocity Systolic Blood Pressure Index in Accurately Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy
Background: Cerebral hyperperfusion syndrome (CHS) is a life threatening complication of
carotid endarterectomy (CEA) and the changes of middle cerebral artery velocity are used to
predict the occurrence of CHS but the accuracy is limited. In addition, changes of BP
post-operatively comparing with baseline BP should be a predictive factor of CHS.
Objective: The investigators aimed to create a predictive index, velocity systolic blood
pressure index (VSI), for improving the predictive power of Transcranial Doppler monitoring
regarding CHS.
Methods: The study design is a diagnostic test, which is an observational analytic clinical
study. From March 2013 to September 2014, 200 patients will be recruited. Patients will be
classified according to the CHS occurrence. VSI combined the changes of middle cerebral
artery velocity and blood pressure crossing CEA and the intra- and post-operative increase
ratios of middle cerebral artery velocity were calculated. Their prediction power of CHS
will be compared. Sensitivity, specificity, positive predictive value, negative predictive
value of them will be calculated. Receiver operating characteristic analysis will be
performed.
Expected Outcomes: Comparing with the commonly used intra-operative and post-operative TCD
monitoring, VSI may be more useful to select CHS in patients who underwent CEA. As far as
the investigators know, analysis or studies combining the BP and velocity changes in the
prediction of CHS have never been performed.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Age from 30 to 85 years; 2. Had a middle-grade symptomatic carotid stenosis (more than 50%) or a high-grade asymptomatic carotid stenosis (more than 70%); 3. Underwent CEA 30 days after the last ischemic cerebrovascular event in the case of symptomatic carotid stenosis; 4. Signed the ethical information consent form 5. Underwent TCD study intraoperative and immediately after CEA; 6. The degree of carotid stenosis will be assessed by CT angiography or cerebral digital subtraction angiography (DSA). (The method document came from the North American Symptomatic Carotid Endarterectomy Trial study.) Exclusion Criteria: 1. Emergency CEA within 30 days of stroke onset in the case of symptomatic carotid stenosis; 2. No temporal windows to measure the MCAV. 3. Restenosis after CEA or CAS 4. Stenosis caused by non-atherosclerotic diseases 5. Combined severe systematic diseases that markedly decrease the life cycle 6. Allergy to medicines of the study such as Aspirin or Statin 7. Refuse to sign the ethical information consent form |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | vascular surgery department of PUMCH | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cerebral hyperperfusion syndrome | CHS will be diagnosed if (1) the patient developed symptoms that ipsilateral moderate or severe headache, confusion, seizures, intracranial hemorrhage or focal neurological deficits after a symptom-free interval. (2) symptoms not secondary to cerebral ischemia which will be excluded by CT or MRI. (3) MCAV increasing >100% from baseline which identified by TCD. (4) within 7 days after surgery. (5) An independent neurologist made the diagnosis of CHS. | within 7 days after surgery | No |
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