Early Warning and Optimization Strategy in Carotid Endarterectomy

NCT01210937 | Unknown Phase 4 DMC

• 1 other identifier: pumch-CAS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Carotid Stenosis; Carotid Artery Diseases; Stroke; Vascular Diseases

Keywords

Internal Carotid Artery Stenosis; Carotid Endarterectomy; Stroke; Cerebrovascular; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• cardiac and neurological morbidity (TIA and CVA)

  12 months

• brain hyperperfusion

  12 months

• long term recurrence

  12 months

Study Arms (1)

CEA and TCD monitoring

EXPERIMENTAL

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

Interventions

CEA and TCD monitoring PROCEDURE

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.

CEA and TCD monitoring

Eligibility Criteria

• Age: 40 Months - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Links

• the website of the vascular surgery department of PUMCH

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases; Stroke; Vascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Cardiovascular Diseases; Arteriosclerosis

Study Officials

• Liu Changwei, bachelor

  STUDY CHAIR

• Liu Bao, doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgery

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: December 24, 2012

Record last verified: 2010-09

Locations

CN (1)