Bacteria in Atherosclerotic Plaques and Adverse Events

Summary

This study is a prospective, multicenter cohort study conducted in western China.

The registry study is primarily conducted at the Department of Neurosurgery, Tangdu Hospital, with participation from the Departments of Neurosurgery at Xi'an Medical University Second Affiliated Hospital, Hanzhong Central Hospital, Hanzhong 3201 Hospital, Baoji People's Hospital, and Pucheng County People's Hospital. The study population consists of patients aged 18 to 90 years undergoing carotid endarterectomy. Patients meeting all inclusion criteria and none of the exclusion criteria may be considered for enrollment after demonstrating informed consent to participate in this registry study and agreeing to sign the informed consent form.

All patients enrolled in this study underwent a comprehensive standardized assessment by a multidisciplinary team (including neurology, neurosurgery, laboratory medicine, endocrinology, ultrasound, and other practitioners). The assessment included examinations of neurological, neuropsychological, and psychiatric conditions; endocrine disorders; and hematological indicators. Bacterial species identification was performed using 16S rDNA sequencing, with further validation via transmission electron microscopy.

Included patients will undergo routine surgical treatment and follow-up visits as recommended by physicians, with corresponding clinical practice data accurately recorded. Data generated during patient clinical visits will be documented, including preoperative assessment, preoperative care, operating room care, anesthesia management, intraoperative procedures, postoperative medical management, postoperative nursing care, and follow-up information.

Inclusion Criteria

1. Patients with clinically diagnosed moderate-to-severe carotid artery stenosis;
2. Age 18 years ≤ age ≤ 90 years;
3. Patients undergoing carotid endarterectomy (CEA) treatment;
4. Preoperative modified Rankin Scale (mRS) score for stroke patients: 0-2;
5. Preoperative NIHSS score for stroke patients: 0-20;
6. Glasgow Coma Scale (GCS) score of 8-15 at hospital admission;
7. No fever or evidence of infection at admission;
8. Informed consent obtained from the subject or legal representative;
9. Good compliance with follow-up requirements.

Exclusion Criteria

1. Brain tumors (with mass effect);
2. Patient's Glasgow Coma Scale (GCS) score \<8;
3. Refractory hypertension (defined as sustained systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) unresponsive to medical therapy
4. History of severe infection within the past three months;
5. Severe or acute heart failure;
6. Acute myocardial infarction or severe arrhythmia;
7. Undergone solid organ surgery or biopsy within the past month;
8. Active bleeding or recent bleeding (gastrointestinal, urinary tract, etc.) within the past month;
9. Currently undergoing hemodialysis or peritoneal dialysis; known severe renal impairment (glomerular filtration rate \<220 mmol/L \[2.5 mg/dL\]);
10. Concurrent malignancy, severe cardiopulmonary disease, or other conditions rendering the patient unable to tolerate surgery;
11. Participation in other interventional clinical studies that may affect outcome assessment;
12. Severe hepatic dysfunction;
13. Other conditions deemed by the investigator as unsuitable for study participation or posing significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders);
14. Current use of immunosuppressive agents or undergoing immunotherapy.
15. Severe chest or abdominal trauma requiring surgical intervention, or severe traumatic brain injury;
16. Infectious diseases such as syphilis, HIV/AIDS, hepatitis, or tuberculosis;
17. Patients concurrently diagnosed with hypertension and diabetes mellitus.

Research Projects and Content

1. Assess bacterial species within carotid plaques to preliminarily identify correlations between bacterial types and different plaque pathologies;
2. Detect plaque bacteria associated with adverse postoperative outcomes (cerebral infarction, carotid restenosis, mortality), identify risk bacteria linked to poor outcomes, and conduct preliminary functional analysis.
3. Analyze clinical data to assess the correlation between postoperative adverse events and bacteria within high-risk plaques, adjusting for confounding factors including age, gender, body mass index, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, creatinine, diabetes, and hypertension to enhance the reliability of research findings.

Conditions

• Carotid Artery Stenosis
• Cerebral Infarction
• Diabetes
• Bacteria
• Bacterial Colonization
• Hypertension
• Carotid Plaque
• Intracellular Bacteria
• Atherosclerosis of Artery
• Bacteria in Plaques

Interventions

PROCEDURE

Carotid Endarterectomy

All enrolled patients underwent carotid endarterectomy. Clinical information and the resected carotid plaques obtained during surgery were utilized for subsequent analytical studies.

Sponsors & Collaborators

• Tang-Du Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2025-07-31

Completion

2025-10-31

Countries

• China