Plummer DiseaseTIROVASCNCT05774535
Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
An observational study of Plummer Disease and Multinodular Goiter, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Plummer Disease, Multinodular Goiter, Graves Disease
- What is being tested?
- Experimental
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the potential eligible candidates will be recruited.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Observational Study on the Investigation of the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
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.
Read more
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.
- Conditions
- Plummer Disease, Multinodular Goiter, Graves Disease, Hyperthyroidism, Euthyroid Goiter, Thyroid Cancer
- Being tested
- Experimental
- Keywords
- carotid intima-media thickness, cardiovascular disease, thyroid disease, carotid artery
- Medical subject headings
- Graves Disease, Hyperthyroidism, Euthyroid Goiter, Thyroid Neoplasms, Cardiovascular Diseases, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients who will undergo thyroidectomy Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
Secondary outcomes (3)
Cumulative incidence of adverse events during periprocedural period
Incidence of death, major stroke, minor stroke, transient ischemic attack
Measured: Within 30 days after the surgery
Cumulative incidence of adverse events during postprocedural period
Incidence of death, major stroke, minor stroke, transient ischemic attack
Measured: 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
Measured: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start5 Sep 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plummer DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774535
- Sponsor's protocol ID
- 34C211
- Acronym
- TIROVASC
- Status last verified
- Sep 2025
- First submitted
- 22 Feb 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study on the Investigation of the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT05774535
- Acronym / sponsor ID
- TIROVASC / 34C211
- Conditions
- Plummer Disease, Multinodular Goiter, Graves Disease, Hyperthyroidism, Euthyroid Goiter, Thyroid Cancer
- Keywords
- carotid intima-media thickness, cardiovascular disease, thyroid disease, carotid artery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: ExperimentalPatients who will undergo thyroidectomy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the potential eligible candidates will be recruited.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalPatients 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. | Other | Experimental |
Primary outcome
Change from baseline in Carotid Intima-Media Thickness (cIMT)
Time frame: 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.
3 secondary outcomes
Cumulative incidence of adverse events during periprocedural period
Time frame: Within 30 days after the surgery
Cumulative incidence of adverse events during postprocedural period
Time frame: Between 30 days after the surgery and 12 months after surgery
Change from baseline in lipid profile
Time frame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Yes
Related trials for Plummer Disease
RecruitingPhase 3
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Hyperthyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plummer Disease and Multinodular Goiter, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Carotid Intima-Media Thickness (cIMT) (time frame: Baseline (10 days before the surgery), 30 days, 6 months and 12 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.