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

NCT ID: NCT05774535

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-08-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental

Patients who will undergo thyroidectomy

Experimental

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano , IRCCS

Milan, , Italy

Countries

Italy

Other Identifiers

34C211

Identifier Type: -

Identifier Source: org_study_id