Early Warning and Optimization Strategy in Carotid Endarterectomy
This study is ongoing, but not recruiting participants.
Sponsor:
Peking Union Medical College Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Constriction, Pathologic Stroke Vascular Diseases Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Cardiovascular Diseases Arterial Occlusive Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013