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Trial Title:
Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
NCT ID:
NCT05774535
Condition:
Plummer Disease
Multinodular Goiter
Graves Disease
Hyperthyroidism
Euthyroid Goiter
Thyroid Cancer
Basedow Disease
Conditions: Official terms:
Graves Disease
Thyroid Diseases
Hyperthyroidism
Goiter
Conditions: Keywords:
carotid intima-media thickness
cardiovascular disease
thyroid disease
carotid artery
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Experimental
Description:
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.
Arm group label:
Experimental
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.
Criteria for eligibility:
Study pop:
All the potential eligible candidates will be recruited.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Auxologico Italiano , IRCCS
Address:
City:
Milan
Zip:
20145
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Renato Casana, MD
Phone:
+3961911
Phone ext:
1
Email:
r.casana@auxologico.it
Investigator:
Last name:
Gianlorenzo Dionigi, MD, Prof
Email:
Principal Investigator
Investigator:
Last name:
Daniele Bissacco, MD
Email:
Sub-Investigator
Investigator:
Last name:
Antonella Pino, MD
Email:
Sub-Investigator
Investigator:
Last name:
Chiara Malloggi, PhD
Email:
Sub-Investigator
Start date:
September 5, 2022
Completion date:
September 2024
Lead sponsor:
Agency:
Istituto Auxologico Italiano
Agency class:
Other
Source:
Istituto Auxologico Italiano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05774535
