SSPC Evaluation on Carotid Artery Stenosis After Endarterectomy (SSPC)

Multi-dimensional Evaluation of Carotid Artery Stenosis and Prediction of Brain Function After Endarterectomy by SSPC System

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Plaque; Carotid Stenosis; Carotid Artery Diseases
• Intervention / Treatment: Procedure: Carotid endarterectomy (CEA)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Jinyun Tan, M.D.; Phone Number: +8613585888537; Email: m.tan@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201200
      • Recruiting
      • Shanghai Pudong Hospital
      • Contact: Jinyun Tan, M.D.; Phone Number: 13585888537; Email: m.tan@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with carotid artery stenosis and fulfilled the above eligible criteria in tertiary medical centers in China, will be enrolled consecutively.

Description

Inclusion Criteria:

1. Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
2. Unilateral or bilateral carotid artery stenosis diagnosed by ultrasound or CT angiography.
3. Complete revascularization followed by carotid endarterectomy or carotid artery stenting.

Exclusion Criteria:

1. Patients with carotid stenosis received best medicine therapy.
2. Patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated.
3. Patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion
4. female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
5. Life expectancy of less than twelve months.
6. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.
7. Patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (> 2.5mg/dl), recent MI or ischemic stroke occurrence (both within 30 days).
8. Patient unwilling or unlikely to comply with Follow-Up schedule

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

carotid endarterectomy; Patients who are treated with CEA under SSPC evaluation

Procedure: Carotid endarterectomy (CEA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Pudong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: carotid stenosis; symptoms; plaque; carotid revascularization; degree of stenosis; cerebral compensation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Stenosis; Carotid Artery Diseases; Constriction, Pathologic
• Other Study ID Numbers: ShanghaiPudong-SSPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No