Hemodynamic Parameters in Euthyroid Patients With Thyroid... | NCT00507897

Studies
Hemodynamic Parameters in Euthyroid Patients With Thyroid Nodules

NCT00507897

Sponsor

Yaroslavl State Medical Academy

Status

Terminated

Last Update Posted

Feb 7, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Thyroid Nodules

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The received reliability with increase in quantity of participants of research did not vary

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Jul 25, 2007

First Submission Date that Met QC Criteria

Jul 26, 2007

First Posted Date

Jul 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2008

Last Update Posted Date

Feb 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Euthyroid patients with thyroid nodules before operation on the thyroid gland

Exclusion Criteria:

Hyperthyroidism
Hypothyroidism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuriy Alexandrov, Professor	Yaroslavl State Medical Academy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yaroslavl State Medical Academy		Yaroslavl		150000	Russia

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided