NCT04236232

Brief Summary

This research aims to evaluate the relation between SCH and cardiovascular System by assessment of lipid profile and carotid intima-media thickness (CIMT), as a marker of atherosclerosis, and endothelial function.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

September 24, 2019

Last Update Submit

January 17, 2020

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (1)

  • Our data will reveale that SCH is associated with increase in CIMT and presence of carotid plaques,and these patients have an increased risk of cardiovascular disease compared with healthy patients.

    The study Will include 50 patients with newly diagnosed SCH, and 50 healthy controls. Body mass index (BMI), TSH, fT4, lipids, blood pressure, mean and maximum carotid intima-media thickness (CIMT) will be determined in all participants.

    Baseline

Study Arms (2)

Patients who will be diagnosed as Subclinical Hypothyroidism

50 pt who will be diagnosed as Subclinical Hypothyroidism by elevated level of TSH (TSH: \>4.5 mu/l) and normal T4

Diagnostic Test: Thyroid function

Patients with normal thyroid function

50 pt with normal thyroid function (TSH \&T4)

Diagnostic Test: Thyroid function

Interventions

Thyroid functionDIAGNOSTIC_TEST

Thyroid function,Lipid Profile, systolic Blood pressure ,diastolic blood pressure .Body Mass Index ,CRP,Echocardiography،ECG, Ultrasonography of Carotid artery

Also known as: Thyroid function,Lipid Profile, systolic Blood pressure ,diastolic blood pressure .Body Mass Index ,CRP,Echocardiography،ECG, Ultrasonography of Carotid artery
Patients who will be diagnosed as Subclinical HypothyroidismPatients with normal thyroid function

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who will be diagnosed as SCH, will present to Outpatient clinic of Assiut University hospitals

You may qualify if:

  • All healthy adult who will be diagnosed as SCH along with age ≥18 \& gender-matched healthy relatives with normal thyroid function will be screened for evidence of high cardiovascular risk.

You may not qualify if:

  • Hypo or hyper-thyroidism, Diabetes, Hypertension, cardiovascular disease, smokers, pregnant and lactating women.
  • Patients who had been treated with anti-thyroid drugs, radio iodine therapy or thyroxin hormone supplement or who had under gone thyroid surgery, those with a history of thyroid cancer or head and neck malignancies.
  • Those with history of drug use such as Contraceptive pill, Anti-depressant drugs, Corticosteroids, Anti arrhythmic drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Sun J, Yao L, Fang Y, Yang R, Chen Y, Yang K, Tian L. Relationship between Subclinical Thyroid Dysfunction and the Risk of Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. Int J Endocrinol. 2017;2017:8130796. doi: 10.1155/2017/8130796. Epub 2017 Aug 31.

    PMID: 29081800BACKGROUND

  • Floriani C, Gencer B, Collet TH, Rodondi N. Subclinical thyroid dysfunction and cardiovascular diseases: 2016 update. Eur Heart J. 2018 Feb 14;39(7):503-507. doi: 10.1093/eurheartj/ehx050.

    PMID: 28329380BACKGROUND

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroid Function TestsUltrasonography, Carotid Arteries

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, EndocrineDiagnostic Techniques and ProceduresDiagnosisUltrasonographyDiagnostic Imaging

Central Study Contacts

Randa Mahrous Roushdy

CONTACT

01288537350randama7rous@yahoo.co

Manal El Sayed Ez El Deen, Ass.prof

CONTACT

01005826070manal_ezeldeen@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 24, 2019

First Posted

January 22, 2020

Study Start

February 1, 2020

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01