Accuracy of TCD Monitoring in Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy
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|ClinicalTrials.gov Identifier: NCT01799070|
Recruitment Status : Unknown
Verified February 2013 by Liu Bao, Peking Union Medical College Hospital.
Recruitment status was: Not yet recruiting
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
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.
|Condition or disease|
|Carotid Stenosis Cerebral Hyperperfusion Syndrome Blood Pressure|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Velocity Systolic Blood Pressure Index in Accurately Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2014|
- cerebral hyperperfusion syndrome [ Time Frame: within 7 days after surgery ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799070
|Contact: Bao Liu, MDfirstname.lastname@example.org|
|vascular surgery department of PUMCH|
|Beijing, Beijing, China, 100730|
|Principal Investigator: Bao Liu, MD|
|Principal Investigator: Changwei Liu, MD|
|Sub-Investigator: Zhichao Lai, MD|