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

NCT01799070 | Unknown DMC

• 2 other identifiers: PUMCH-20130113B2009B080
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prediction; Transcranial Doppler

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CHS

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who with carotid stenosis will accept CEA in PUMCH from March 2013 to September 2014.

You may qualify if:

• Age from 30 to 85 years;
• Had a middle-grade symptomatic carotid stenosis (more than 50%) or a high-grade asymptomatic carotid stenosis (more than 70%);
• Underwent CEA 30 days after the last ischemic cerebrovascular event in the case of symptomatic carotid stenosis;
• Signed the ethical information consent form
• Underwent TCD study intraoperative and immediately after CEA;
• 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.)

You may not qualify if:

• Emergency CEA within 30 days of stroke onset in the case of symptomatic carotid stenosis;
• No temporal windows to measure the MCAV.
• Restenosis after CEA or CAS
• Stenosis caused by non-atherosclerotic diseases
• Combined severe systematic diseases that markedly decrease the life cycle
• Allergy to medicines of the study such as Aspirin or Statin
• Refuse to sign the ethical information consent form

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

vascular surgery department of PUMCH

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Bao Liu, MD

CONTACT

+86-10-88068230; liubao72@yahoo.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 24, 2013
• First Posted: February 26, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

CN (1)