Prospective, Observational Study on the Investigation of the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from baseline in Carotid Intima-Media Thickness (cIMT)
研究概览
简要总结
The evaluation of carotid intima-media thickness (cIMT) has become a possible predictor of the future risk of cardiovascular diseases (CVD). Evidence to date shows that cIMT augmentation is correlated with the extent of atherosclerosis in the coronary arteries and with other risk factors for CVD. More recently, several studies have evaluated the association of cIMT with stroke, to determine whether this measure can also predict future cardiovascular events.
Although the published evidence is scarce and fragmentary, the cIMT retains an increasingly interesting role as a marker of atherosclerotic pathology.
The purpose of the study is to analyze cIMT in patients undergoing thyroidectomy to evaluate a possible correlation between the cIMT variation after the procedure and the cause of the thyroid disease, the levels of thyroid hormones, and the lipid or other markers of atherosclerosis levels.
The primary endpoint will be the variation of the measure of the cIMT before and after surgery.
Secondary endpoints will be:
- major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the short-term period (≤30 days after the procedure);
- major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the long-term period (>30 days after the procedure);
- the technical success of the procedure;
- the rate of postoperative complications. To date, there are no data that differentiate patients based on the causes of thyroid disease. The results of the present study will allow for correlating the variation of the cIMT to the causes of thyroid disease, the levels of thyroid hormones, and the levels of lipid and other markers of atherosclerosis.
Results from the present study may provide insights into possible areas of quality improvement. It may also influence the economic impact associated with carotid revascularization techniques, in terms of hospital charges and discharges to skilled nursing and rehabilitation facilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing thyroidectomy according to the American Thyroid Association (ATA), International neural monitoring study group guideline (INMSG), Italian Society of Endocrine Surgery (SIUEC);
- •subjects who have read and signed the informed consent;
- •subjects who undertake to undergo the instrumental examinations and visits necessary for the study during the follow-up;
- •>18 years of age.
排除标准
- •occlusion or stenosis of at least one carotid artery, with plaque > 30%;
- •exposure to ionizing radiation;
- •previous neck, carotid (endarterectomy or stenting) and/or thyroid surgery;
- •clinical conditions that preclude proper follow-up;
- •HIV, dialysis therapy and all clinical conditions with increased cIMT;
- •uncontrolled dyslipidemia;
- •pregnant and breastfeeding women;
- •terminal patients.
结局指标
主要结局
Change from baseline in Carotid Intima-Media Thickness (cIMT)
时间窗: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
cIMT is a measurement of the thickness of tunica intima and tunica media, the innermost two layers of the wall of an artery. The measurement is made by external ultrasound according to the recommendation of the Joint Carotid Intima-Media Thickness and Plaque Area Measurement in Ultrasound for Cardiovascular/Stroke Risk Monitoring.
次要结局
- Cumulative incidence of adverse events during periprocedural period(Within 30 days after the surgery)
- Change from baseline in lipid profile(Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery)
- Cumulative incidence of adverse events during postprocedural period(Between 30 days after the surgery and 12 months after surgery)