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临床试验/NCT06409520
NCT06409520招募中不适用

Impact Of Subclinical Hypothyroidism On Short-Term Outcomes In Patients With Acute Coronary Syndrome In Sohag University Hospitals

Sohag University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Short-term complications

研究概览

简要总结

Introduction:

Subclinical hypothyroidism (SCH) is defined biochemically as a normal serum free thyroxine (T4) level in the presence of an increased serum thyroid stimulating hormone (TSH) concentration.(1) Its prevalence ranges from 4 to 15 percent and is higher in females and increasing age.(2) Overt hypothyroidism was associated with accelerated atherosclerosis and an increased risk of cardiovascular abnormalities. (3) Some studies have reported a higher atherosclerotic cardiovascular disease risk in patients with SCH. (5-8) Elevated TSH levels were observed to be associated with higher cholesterol levels.(9) Higher mortality was also reported in some studies (6,10) especially with TSH ≥ 10.0 mIU/L, in contrast to other studies.(11,12) Heart failure events and myocardial infarction have been reported to be higher.(13,14) These findings in SCH patients could be explained by mitochondrial oxidative stress due to elevated inflammatory markers, hypercoagulability, endothelial dysfunction, insulin resistance, increased vascular resistance and left ventricular diastolic and systolic dysfunction.(3,15,16) As is the case with overt hypothyroidism, SCH was observed to be associated with elevated peripheral vascular resistance and diastolic dysfunction.(17) There are a few studies evaluating the effects of subclinical hypothyroidism on the outcomes of acute coronary syndrome patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Adult patients (age ≥18 years) diagnosed with acute coronary syndrome

排除标准

  • Patients with overt hypothyroidism or hyperthyroidism.
  • Pregnant and lactating females
  • Patients with severe comorbid conditions e.g. Malignancy decompensated liver diseases or end stage kidney diseases.
  • Patients with a history of taking medications affecting thyroid function

结局指标

主要结局

Short-term complications

时间窗: 1 year

events during hospitalisation will be documented, and patients will be followed up for 30 days. The documented inhospital events include cardiogenic shock, Ejection fraction less than 40%, Killip class more than one, new atrial fibrillation, sudden cardiac arrest, bradyarrhythmia necessitating pacing, major bleeding necessitating blood transfusion, and acute kidney injury while hospitalized

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

Amr Ibrahim Abd El-haleem Adam

Assistant lecturer internal medicine sohag university

Sohag University

研究点 (1)

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