跳至主要内容
临床试验/NCT04236232
NCT04236232Unknown不适用

The Impact of Subclinical Hypothyroidism on the Cardiovascular System

Assiut University0 个研究点目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
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.

研究概览

简要总结

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.

详细描述

Subclinical hypothyroidism (SCH) is defined as a condition that characterized by elevated serum thyroid-stimulating hormone (TSH) concentrations (TSH: >4.5 mu/l), while circulating thyroxine (T4) and tri- iodothyronine (T3) levels remain within the normal range.

Depending on the extent of serum TSH elevation, SCH can be divided into Mild (where the concentration of serum TSH is in the range of 4.5-9 mU/l) Severe (TSH≥10 mU/l) SCH. Mild SCH constitutes ~75% of the total number of patients with SCH. The incidence of SCH varies between 5 and 10 % depending upon the gender, age, more frequent in women than in men, with increasing prevalence with advanced age in both sexes The consequences of SCH are variable at several levels and may depend on the duration and the degree of increasing level of the serum TSH. However, a number of important questions about SCH remain, including whether it increases cardiovascular (CVS) risk or not.

SCH has many causes the most common (60% to 80%) is chronic autoimmune thyroiditis associated with the presence of circulating anti-thyroid peroxidase antibodies(TPOAb) that are the most sensitive serological test for thyroid autoimmunity and/or antithyroglobulin Antibodies(TgAb).

The association between subclinical hypothyroidism (SCH) and cardiovascular disease has received increasing attention in recent years.

Thyroid hormones exert a direct effect on the heart and blood vessels. The deficit of these hormones leads to functional disorders of the Cardiovascular System (CVS) such as changes in cardiac frequency, cardiac output, left ventricular diastolic dysfunction, and reduced resting and exceptional systolic function.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: Baseline

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randa Mahrous Roushdy

Resident doctor

Assiut University

相似试验

The Impact of Subclinical Hypothyroidism on... | 临床试验