Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction

Conditions
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Myocardial Infarction, Hypothyroidism

Intervention / Treatment
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* Drug: Levothyroxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levothyroxine group<br>The patients allocated to levothyroxine group receive levothyroxine with a starting dose of 12.5ug. | Drug: Levothyroxine<br>* Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.<br>* Other names: Euthyrox;|
| No Intervention: Standard therapy group<br>The patients in this group receive standard therapy in consistent with the local clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging |  | within 6 months of patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident. | within 12 months of patient enrolled | 
| Death by any cause |  | Within 12 months of patient enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, hypothyroidism, levothyroxine, cardiac magnetic resonance imaging, myocardial perfusion/metabolism radionuclide imaging, myocardial fibrosis, myocardial perfusion/metabolism, cardiac function