A Phase 4 interventional study of Levothyroxine in Myocardial Infarction and Hypothyroidism, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-16.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Phase 4, Interventional, and Treatment
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 160 is close to the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug.
Drug: Levothyroxine
The patients in this group receive standard therapy in consistent with the local clinical practice.
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Also known as: Euthyrox
The 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
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital