Clinical trial NCT05774535: Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Official title: Prospective, Observational Study on the Investigation of the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plummer Disease
Multinodular Goiter
Graves Disease
Hyperthyroidism
Euthyroid Goiter
Thyroid Cancer
Basedow Disease
Keywords: carotid intima-media thickness
cardiovascular disease
thyroid disease
carotid artery
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the potential eligible candidates will be recruited.

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.


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.

Primary outcomes:
measure: Change from baseline in Carotid Intima-Media Thickness (cIMT)
timeFrame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
Secondary outcomes:
measure: Cumulative incidence of adverse events during periprocedural period
timeFrame: Within 30 days after the surgery
measure: Cumulative incidence of adverse events during postprocedural period
timeFrame: Between 30 days after the surgery and 12 months after surgery
measure: Change from baseline in lipid profile
timeFrame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano , IRCCS
Study officials:
References: