Thyroid Hormone Replacement After Coronary Artery Bypass Grafting for Patients With Subclinical Hypothyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- A composite of MACE within 4months after surgery
研究概览
简要总结
The goal of this clinical trial is to find out whether levothyroxine reduces complications and improves the prognosis of patients with subclinical hypothyroidism (SCH) undergoing coronary artery bypass grafting (CABG).
The main questions this study aims to answer are:
• Does levothyroxine reduce major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and new arrhythmias, in SCH patients undergoing CABG? Researchers will compare patients who take levothyroxine with those who do not.
Participants will:
- Be randomly assigned to either receive levothyroxine or not
- Start the medication one day before surgery if assigned to the treatment group.
- Have regular follow-up visits to check thyroid function and cardiovascular events for up to five years after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Adults aged 19 to 90 years.
- •Patients scheduled to undergo coronary artery bypass graft (CABG) surgery.
- •Subclinical hypothyroidism (SCH), defined as a normal free thyroxine (free T4) level and a thyroid-stimulating hormone (TSH) level greater than 4 μIU/mL, based on testing performed within 31 days prior to surgery.
排除标准
- •Patients who underwent repeat or emergency CABG surgery
- •Use of LT4 within the previous 4 weeks
- •Use of antithyroid drug use (propylthiouracil, methimazole, or carbimazole) within the previous 3 months
- •Severe comorbid conditions with a life expectancy of less than 1 year (e.g. advanced malignancy)
研究组 & 干预措施
LT4 group
Participants in this group will receive levothyroxine
干预措施: levothyroxine (Drug)
Control group
Participants in this group will not receive levothyroxine
结局指标
主要结局
A composite of MACE within 4months after surgery
时间窗: within 4months after surgery
A composite of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and the occurrence of new arrhythmias assessed within 4 months after CABG.
次要结局
- Number of participants who experience cardiovascular death within 4 months after surgery(within 4months after surgery)
- Number of participants who experience nonfatal myocardial infarction within 4 months after surgery(within 4months after surgery)
- Number of participants who experience nonfatal stroke within 4 months after surgery(within 4months after surgery)
- Number of participants who experience new arrhythmia within 4 months after surgery(within 4months after surgery)
- A composite of MACE within 1 year after surgery(within 1 year after surgery)
- A composite of MACE within 5 year after surgery(within 5 years after surgery)
- All-cause mortality within 5 years after surgery(within 5 years after surgery)
- Change in LVEF from baseline to 1 year after surgery(From baseline to 1 year after surgery)
- Change in LV EDD from baseline to 1 year after surgery(From baseline to 1 year after surgery)
- Change in LV ESD from baseline to 1 year after surgery(From baseline to 1 year after surgery)
- Change in LVMI from baseline to 1 year after surgery(From baseline to 1 year after surgery)
- Change in LAMI from baseline to 1 year after surgery(From baseline to 1 year after surgery)
研究者
Min Joo Kim
Professor of Internal Medicine
Seoul National University Bundang Hospital