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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Fuwai Cardiovascular Hospital
Beijing, China
RECRUITINGThe improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging
Time frame: within 6 months of patient enrolled
Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging
Patterns of myocardial perfusion/metabolism were classified as normal, mismatch, mild-moderate match and severe match
Time frame: Within 6 months of patient enrolled
The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)
Time frame: Within 6 months of patient enrolled
Major adverse cardiac and cerebrovascular events
The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident.
Time frame: within 12 months of patient enrolled
Death by any cause
Time frame: Within 12 months of patient enrolled
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