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

Recruiting

• Conditions: Plummer Disease; Euthyroid Goiter; Thyroid Cancer; Basedow Disease; Hyperthyroidism; Graves Disease; Multinodular Goiter
• Interventions: Other: Experimental

• Registration Number: NCT05774535
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-05
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Experimental	Patients who will undergo thyroidectomy

Primary Outcome Measures

Name	Time	Method
Change from baseline in Carotid Intima-Media Thickness (cIMT)	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of adverse events during periprocedural period	Within 30 days after the surgery	Incidence of death, major stroke, minor stroke, transient ischemic attack
Change from baseline in lipid profile	Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery	Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol
Cumulative incidence of adverse events during postprocedural period	Between 30 days after the surgery and 12 months after surgery	Incidence of death, major stroke, minor stroke, transient ischemic attack

Trial Locations

Locations (1)

Istituto Auxologico Italiano , IRCCS; 🇮🇹 Milan, Italy