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SSPC includes degree of Stenosis, Symptoms, Plaque stability and Compensation of the cerebral blood flow. SSPC, a comprehensive evaluation system on carotid artery stenosis, is established and advocated in this trial in order to make assessment on risk of carotid revascularization preoperatively and prediction of cerebral events postoperatively.
Although, cerebral perfusion and collaterals recruitment are crucial and integral to current treatment and stroke prevention paradigms, most consensus recommendations do not include assessments of cerebral hemodynamics in their management algorithms and arbitrarily focus on symptoms and degree of stenosis.
Based on four aspects of SSPC multidimensional assessment and grading, through clinical data, specimen collection, image technology of the multi-disciplinary cross research, we initially to propose a more scientific evaluation system for the perioperative period of carotid revascularization, to reveal the scientific mechanism of brain function changes after carotid revascularization, and to establish a method for the evaluation of brain function after carotid revascularization in accordance with the characteristics of Chinese lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carotid endarterectomy | Patients who are treated with CEA under SSPC evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid endarterectomy (CEA) | Procedure | Surgeons follow the contemporary guideline combined with their experience and preference in order to perform CEA for patients. All patients will be assessed by SSPC evaluation system before CEA. Patients will receive 100 mg of aspirin or 75 mg of clopidogrel daily starting from at least 72 h prior to the CEA procedure and continued receiving the medication indefinitely. General anesthesia is recommended for CEA and the type of CEA can be selected as conventional, eversion or a shunt or patch based on the discretion of the surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke or TIA within 12 months | Number of participants with treatment-Stroke or TIA within 12 months | within 12 months post-procedure |
| Immediate neurologic events within 24 hours | Number of participants with treatment-immediate neurologic events including cerebral hyperperfusion syndrome, early-phase hypertension and cerebral hemorrhage within 24 hours | within 24 hours post-procedure |
| Cognition improvements | Cognition improvements indicated by MMSE (Mini-mental State Examination) or MoCA (Montreal Cognitive Assessment) or Cantab (Cambridge Neuropsychological Test Automated Battery) | within 1, 3, 6, 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Infarction or death within 1 month | Number of participants with treatment-Myocardial Infarction or death within 1 month | within 1 month post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with carotid artery stenosis and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Yu, M.D. | Contact | +8618918922698 | paul.yubo@gmail.com | |
| Jinyun Tan, M.D. | Contact | +8613585888537 | m.tan@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pudong Hospital | Recruiting | Shanghai | Shanghai Municipality | 201200 | China |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D002340 | Carotid Artery Diseases |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |