ClinicalTrials.gg
WithdrawnNCT05774535TIROVASCUpdated Oct 2, 2025

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

An observational study in Plummer Disease, Multinodular Goiter and Graves Disease, sponsored by Istituto Auxologico Italiano. Withdrawn at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Istituto Auxologico Italiano · Observational

Why this study was withdrawn
No enrollment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Plummer Disease
  • Multinodular Goiter
  • Graves Disease
  • Hyperthyroidism
  • Euthyroid Goiter
  • Thyroid Cancer
  • Basedow Disease

Keywords

  • carotid intima-media thickness
  • cardiovascular disease
  • thyroid disease
  • carotid artery
03

In context

Graves Disease

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

Browse Graves Disease studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All the potential eligible candidates will be recruited.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ;
  • subjects who undertake to undergo the instrumental examinations and visits necessary for the study during the follow-up;
  • >18 years of age.

Exclusion criteria

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;
  • , dialysis therapy and all clinical conditions with increased cIMT;
  • uncontrolled dyslipidemia;
  • pregnant and breastfeeding women;
  • terminal patients.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental

    Patients who will undergo thyroidectomy

    Other: Experimental

Interventions

  • OtherExperimental

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery

Secondary outcomes

  1. Cumulative incidence of adverse events during periprocedural period

    Incidence of death, major stroke, minor stroke, transient ischemic attack

    Time frame: Within 30 days after the surgery

  2. Cumulative incidence of adverse events during postprocedural period

    Incidence of death, major stroke, minor stroke, transient ischemic attack

    Time frame: Between 30 days after the surgery and 12 months after surgery

  3. Change from baseline in lipid profile

    Total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol

    Time frame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery

07

Study locations

1 site
  • Istituto Auxologico Italiano , IRCCS
    Milan, 20145, Italy
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Aug 2024, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2023
First posted
Mar 17, 2023
StartActual
Sep 5, 2022
Primary completionActual
Aug 31, 2024
CompletionActual
Aug 31, 2024
Last update
Oct 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05774535
Responsible party
Sponsor
First posted
Mar 17, 2023
Start date
Sep 5, 2022
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024
Last update
Oct 2, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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