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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Patients who will undergo thyroidectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | 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:
The following assessments will be performed after 30 days, 6 months and 12 months from the thyroidectomy procedure:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Carotid Intima-Media Thickness (cIMT) | 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. | Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of adverse events during periprocedural period | Incidence of death, major stroke, minor stroke, transient ischemic attack | Within 30 days after the surgery |
| Cumulative incidence of adverse events during postprocedural period |
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Inclusion Criteria:
Exclusion Criteria:
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All the potential eligible candidates will be recruited.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano , IRCCS | Milan | 20145 | Italy |
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|
Incidence of death, major stroke, minor stroke, transient ischemic attack
| Between 30 days after the surgery and 12 months after surgery |
| Change from baseline in lipid profile | Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol | Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery |
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| C562732 | Euthyroid Goiter |
| D013964 | Thyroid Neoplasms |
| D002318 | Cardiovascular Diseases |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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