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Early Warning and Optimization Strategy in Carotid Endarterectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Liu Chang-wei, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01210937
First received: September 28, 2010
Last updated: December 20, 2012
Last verified: September 2010
  Purpose

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 .


Condition Intervention Phase
Carotid Stenosis
Carotid Artery Diseases
Stroke
Vascular Diseases
Procedure: CEA and TCD monitoring
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Warning and Optimization Strategy in Carotid Endarterectomy

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • brain hyperperfusion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • long term recurrence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CEA and TCD monitoring
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
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.

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.

  Eligibility

Ages Eligible for Study:   40 Months to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210937

Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Liu Changwei, bachelor
Principal Investigator: Liu Bao, doctor
  More Information

Additional Information:
No publications provided

Responsible Party: Liu Chang-wei, Vascular Surgery, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01210937     History of Changes
Other Study ID Numbers: pumch-CAS
Study First Received: September 28, 2010
Last Updated: December 20, 2012
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Internal Carotid Artery Stenosis
Carotid Endarterectomy
Stroke
Cerebrovascular
Atherosclerosis

Additional relevant MeSH terms:
Carotid Artery Diseases
Carotid Stenosis
Vascular Diseases
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014