Early Warning and Optimization Strategy in Carotid Endarterectomy

Study Overview
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Brief Summary
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Carotid endarterectomy has been proven effective in prevention of cerebral vascular events in patients with severe carotid artery stenosis (symptomatic,>50%;asymptomatic,60%). But during the surgery, when the carotid artery is clipping, the patient will have the chance to have hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce the risk of death and nonfatal stroke in patients .

Detailed Description
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AHA guidelines recommend carotid endarterectomy (CEA) for severe carotid stenosis. But during CEA, there is little chance that the patient suffer from severe hypoperfusion or stroke. So we use TCD to monitor the blood flow of brain in the surgery and keep the blood pressure stable. The sudy is designed to find out whether the index which we found in previous work is more sensitive to show the blood flow of middle cerebral artery.

Official Title
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Early Warning and Optimization Strategy in Carotid Endarterectomy

Conditions
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Carotid Stenosis, Carotid Artery Diseases, Stroke, Vascular Diseases

Intervention / Treatment
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* Procedure: CEA and TCD monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carotid artery stenosis detectable by duplex ultrasound, and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS. Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG) Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years) Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA . Exclusion Criteria: Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer)

Ages Eligible for Study
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Minimum Age: 40 Months
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEA and TCD monitoring<br>CEA involves a neck incision and physical removal of the plaque from the inside of the artery.During the surgery, the patient will be monitored by TCD. | Procedure: CEA and TCD monitoring<br>* All patients will receive carotid endarterectomy. During the surgery, all of them will be monitored by TCD. Record the blood flow velocity and blood pressure on specified time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac and neurological morbidity (TIA and CVA) |  | 12 months | 
| brain hyperperfusion |  | 12 months | 
| long term recurrence |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis