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Accuracy of TCD Monitoring in Predicting Cerebral Hyperperfusion Syndrome After Carotid Endarterectomy

NCT01799070 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2013-02-26

No results posted yet for this study

Summary

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.

Conditions

  • Carotid Stenosis
  • Cerebral Hyperperfusion Syndrome
  • Blood Pressure

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01799070 on ClinicalTrials.gov