NCT05774535

Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery

Prospective, Observational Study on the Investigation of the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plummer Disease
• Multinodular Goiter
• Graves Disease
• Hyperthyroidism
• Euthyroid Goiter
• Thyroid Cancer
• Basedow Disease

Interventions

Type	Name	Description
OTHER	Experimental	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.

Timeline

• Start date: 2022-09-05
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-03-17
• Last updated: 2025-10-02

Locations

1 site across 1 country: Italy