Clinical trial NCT02512978: Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI)
Official title: Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Hypothyroidism
Keywords: myocardial infarction
hypothyroidism
levothyroxine
cardiac magnetic resonance imaging
myocardial perfusion/metabolism radionuclide imaging
myocardial fibrosis
myocardial perfusion/metabolism
cardiac function
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
name: Peking Union Medical College Hospital
name: Peking University Third Hospital
name: Beijing Anzhen Hospital
name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
name: The Luhe Teaching Hospital of the Capital Medical University
First posted: 2015-07-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 75, male or non-pregnant female;
2. Is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (PCI);
3. With presence of hypothyroid status (i.e., TSH \>7.0 mIU/L and (or) fT3 \<1.79 pg/mL);
4. Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.

Exclusion Criteria:

1. Those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit;
2. Symptoms of severe heart failure (Killip Class III and above);
3. Severely impaired renal function before surgery: serum creatinine \> 2.0mg/dl;
4. Impaired liver function before surgery: Serum GPT \> 120U/L;
5. Those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines;
6. Those taking medicine which can affect the test of thyroid function;
7. Patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months;
8. Those having prior myocardial infarction;
9. Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Primary outcomes:
measure: The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging
timeFrame: within 6 months of patient enrolled
Secondary outcomes:
measure: Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging
timeFrame: Within 6 months of patient enrolled
measure: The severity of myocardial fibrosis assessed by late-gadolinium enhancement cardiac magnetic resonance imaging(cMRI-LGE)
timeFrame: Within 6 months of patient enrolled
measure: Major adverse cardiac and cerebrovascular events
timeFrame: within 12 months of patient enrolled
measure: Death by any cause
timeFrame: Within 12 months of patient enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Cardiovascular Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yi-Da Tang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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