Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging
研究概览
简要总结
Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
详细描述
The primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for AMI is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75, male or non-pregnant female;
- •Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);
- •With presence of hypothyroid status (i.e., TSH >7.0 mIU/L and (or) fT3 <1.79 pg/mL);
- •Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
排除标准
- •Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;
- •Symptoms of severe heart failure (Killip Class III and above);
- •Severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
- •Impaired liver function before surgery: Serum GPT > 120U/L;
- •Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;
- •Those taking medicine which can affect the test of thyroid function;
- •Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;
- •Those having prior myocardial infarction;
- •Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
研究组 & 干预措施
Levothyroxine group
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
干预措施: Levothyroxine (Drug)
结局指标
主要结局
The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging
时间窗: within 6 months of patient enrolled
次要结局
- Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging(Within 6 months of patient enrolled)
- The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)(Within 6 months of patient enrolled)
- Major adverse cardiac and cerebrovascular events(within 12 months of patient enrolled)
- Death by any cause(Within 12 months of patient enrolled)
研究者
Yi-Da Tang
Professor
Chinese Academy of Medical Sciences, Fuwai Hospital