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Early Warning and Optimization Strategy in Carotid Endarterectomy

Primary Purpose

Carotid Stenosis, Carotid Artery Diseases, Stroke

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CEA and TCD monitoring
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis

Eligibility Criteria

40 Months - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CEA and TCD monitoring

Arm Description

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.

Outcomes

Primary Outcome Measures

Mortality
The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure

Secondary Outcome Measures

cardiac and neurological morbidity (TIA and CVA)
brain hyperperfusion
long term recurrence

Full Information

First Posted
September 28, 2010
Last Updated
December 20, 2012
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01210937
Brief Title
Early Warning and Optimization Strategy in Carotid Endarterectomy
Official Title
Early Warning and Optimization Strategy in Carotid Endarterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis, Carotid Artery Diseases, Stroke, Vascular Diseases
Keywords
Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CEA and TCD monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
CEA and TCD monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality
Description
The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure
Time Frame
30 days
Secondary Outcome Measure Information:
Title
cardiac and neurological morbidity (TIA and CVA)
Time Frame
12 months
Title
brain hyperperfusion
Time Frame
12 months
Title
long term recurrence
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Changwei, bachelor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Liu Bao, doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.vascular.cn/
Description
the website of the vascular surgery department of PUMCH

Learn more about this trial

Early Warning and Optimization Strategy in Carotid Endarterectomy

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