Thyroid NodulesNCT00507897
Hemodynamic Parameters in Euthyroid Patients With Thyroid Nodules
An observational study of Thyroid Nodules, run by Yaroslavl State Medical Academy at 1 site in Russia.
Trial summary
The purpose of this study is to determine the relationship of hemodynamic parameters with the level of thyroid hormones and the histological structure of thyroid nodules in euthyroid patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Nodules
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Start not givento Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Euthyroid patients with thyroid nodules before operation on the thyroid gland
Who cannot join
- Hyperthyroidism
- Hypothyroidism
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the relationship of hemodynamic parameters with the level of thyroid hormones and the histological structure of thyroid nodules in euthyroid patients.
Read the detailed description
As opposed to widely investigated condition of cardiovascular system in patients with functional disorders of thyroid gland, the relationship between thyroid hormones and hemodynamic parameters in euthyroid patients remains not enough clear.
We detect the parameters of blood pressure and thyroid hormones in euthyroid patients with thyroid nodules directly before planned operation on the thyroid gland.
As the study is carries out directly before operation, that assumes presence of preoperative stress in patients, activity of the sympatho - adrenal system is estimated in addition.
On the one hand, the design of our research will allow to estimate relationship of thyroid hormones with the parameters of blood pressure in conditions of euthyroidism, on the other hand - to investigate features of blood pressure in patients with thyroid nodules.
The research of the patients in the preoperative period will enable to select the group of patients without pathology of cardiovascular system whose increased blood pressure is connected with preoperative stress, that in turn will allow to exclude influence of the pathology of the cardiovascular system on studied correlation.
- Conditions
- Thyroid Nodules
- Keywords
- thyroid nodules, blood pressure, thyroid hormones
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Cohort: Patients with normal blood pressure scheduled to have thyroid nodules surgically removed | |
| A1 | Patients from group A not receiving any drugs and who lack other pathology, gender and age matched group B1 | |
| B | Cohort: Patients with increased blood pressure scheduled to have thyroid nodules surgically removed | |
| B1 | Patients from group B not receiving any drugs and who lack other pathology, gender and age matched group A1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study completionDec 2007
Why it stopped: The received reliability with increase in quantity of participants of research did not vary
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaroslavl State Medical Academy
- Sponsor type
- University, hospital or other
- Investigators
- Yuriy Alexandrov, Professor, Study chair, Yaroslavl State Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507897
- Sponsor's protocol ID
- ESheverdova-1
- Status last verified
- Feb 2008
- First submitted
- 25 Jul 2007
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Parameters in Euthyroid Patients With Thyroid Nodules
- ClinicalTrials.gov ID
- NCT00507897
- Acronym / sponsor ID
- ESheverdova-1
- Conditions
- Thyroid Nodules
- Keywords
- thyroid nodules, blood pressure, thyroid hormones
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The received reliability with increase in quantity of participants of research did not vary
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yaroslavl State Medical AcademyUniversity, hospital or other
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Jul 2007 (estimated)
- 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 purpose of this study is to determine the relationship of hemodynamic parameters with the level of thyroid hormones and the histological structure of thyroid nodules in euthyroid patients.
Detailed description
As opposed to widely investigated condition of cardiovascular system in patients with functional disorders of thyroid gland, the relationship between thyroid hormones and hemodynamic parameters in euthyroid patients remains not enough clear.
We detect the parameters of blood pressure and thyroid hormones in euthyroid patients with thyroid nodules directly before planned operation on the thyroid gland.
As the study is carries out directly before operation, that assumes presence of preoperative stress in patients, activity of the sympatho - adrenal system is estimated in addition.
On the one hand, the design of our research will allow to estimate relationship of thyroid hormones with the parameters of blood pressure in conditions of euthyroidism, on the other hand - to investigate features of blood pressure in patients with thyroid nodules.
The research of the patients in the preoperative period will enable to select the group of patients without pathology of cardiovascular system whose increased blood pressure is connected with preoperative stress, that in turn will allow to exclude influence of the pathology of the cardiovascular system on studied correlation.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | –Cohort: Patients with normal blood pressure scheduled to have thyroid nodules surgically removed |
| A1 | – | –Patients from group A not receiving any drugs and who lack other pathology, gender and age matched group B1 |
| B | – | –Cohort: Patients with increased blood pressure scheduled to have thyroid nodules surgically removed |
| B1 | – | –Patients from group B not receiving any drugs and who lack other pathology, gender and age matched group A1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Euthyroid patients with thyroid nodules before operation on the thyroid gland
Key exclusion criteria (2 listed)
- Hyperthyroidism
- Hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The received reliability with increase in quantity of participants of research did not vary). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2008.
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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.
Yuriy Alexandrov, Professor study chair
Yaroslavl State Medical Academy
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 Thyroid Nodules, run by Yaroslavl State Medical Academy at 1 site in Russia.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Feb 2008. 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 Russia. 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 stopped early (reason given: The received reliability with increase in quantity of participants of research did not vary). Results are not available in the source record.
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.
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 7 Feb 2008.