Hypothyroidism, Myocardial Infarction
Conditions
Keywords
myocardial infarction, hypothyroidism, levothyroxine, cardiac magnetic resonance imaging, myocardial perfusion/metabolism radionuclide imaging, myocardial fibrosis, myocardial perfusion/metabolism, cardiac function
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.
Interventions
DRUGLevothyroxine
Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
Sponsors
Beijing Municipal Science & Technology Commission
Peking Union Medical College Hospital
Peking University Third Hospital
Beijing Anzhen Hospital
Beijing Chao Yang Hospital
Beijing Friendship Hospital
The Luhe Teaching Hospital of the Capital Medical University
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement of Left Ventricular ejection fraction assessed by cardiac magnetic resonance imaging | within 6 months of patient enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial perfusion and metabolism detected by 99Tcm-MIBI SPECT and 18F-FDG PET imaging | Within 6 months of patient enrolled | Patterns of myocardial perfusion/metabolism were classified as normal, mismatch, mild-moderate match and severe match |
| 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 | The composite endpoint of cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular accident. |
| Death by any cause | Within 12 months of patient enrolled | — |
Countries
China
Contacts
Primary ContactWen-Yao Wang, MD,PhD Candidate
Backup ContactJing Chen, MD
Outcome results
None listed