Early Warning and Optimization Strategy in Carotid Endarterectomy

Stroke Clinical Trial

Official title:

Early Warning and Optimization Strategy in Carotid Endarterectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01210937
• Other study ID #: pumch-CAS
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: December 20, 2012
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2010
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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 .

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Months to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Stenosis
• Stroke
• Vascular Diseases

Intervention

Procedure:
• CEA and TCD monitoring
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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	cardiac and neurological morbidity (TIA and CVA)		12 months	Yes
Secondary	brain hyperperfusion		12 months	Yes
Secondary	long term recurrence		12 months	Yes

External Links

•   the website of the vascular surgery department of PUMCH