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.
Study Type
OBSERVATIONAL
Patients will undergo thyroidectomy according to the guidelines American Thyroid Association (ATA), Randolph. The following assessments will be performed within 10 days before the thyroidectomy procedure: * informed consent; * personal data and medical records; * registration of medical therapy and post-procedural pharmacological protocol * surgical check; * supra-aortic trunks EchocolorDoppler; * pre-procedural blood sampling. The following assessments will be performed after 30 days, 6 months and 12 months from the thyroidectomy procedure: * surgical checks; * registration of drug therapy; * recording of all adverse events that occurred during hospitalization * supra-aortic trunks EchocolorDoppler and cIMT measurement; * blood sampling.
Istituto Auxologico Italiano , IRCCS
Milan, Italy
Change from baseline in Carotid Intima-Media Thickness (cIMT)
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.
Time frame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
Cumulative incidence of adverse events during periprocedural period
Incidence of death, major stroke, minor stroke, transient ischemic attack
Time frame: Within 30 days after the surgery
Cumulative incidence of adverse events during postprocedural period
Incidence of death, major stroke, minor stroke, transient ischemic attack
Time frame: Between 30 days after the surgery and 12 months after surgery
Change from baseline in lipid profile
Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol
Time frame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
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