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The goal of this clinical trial is to find out whether levothyroxine reduces complications and improves the prognosis of patients with subclinical hypothyroidism (SCH) undergoing coronary artery bypass grafting (CABG).
The main questions this study aims to answer are:
• Does levothyroxine reduce major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and new arrhythmias, in SCH patients undergoing CABG? Researchers will compare patients who take levothyroxine with those who do not.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT4 group | Experimental | Participants in this group will receive levothyroxine |
|
| Control group | No Intervention | Participants in this group will not receive levothyroxine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levothyroxine | Drug | Intervention description: Participants assigned to the LT4 group will begin receiving levothyroxine the day before CABG. The initial dose is 25 μg once daily, or 12.5 μg for participants weighing less than 60 kg. The dose will then be adjusted based on thyroid function test results to achieve target TSH levels of 0.4-2.0 μIU/mL. |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of MACE within 4months after surgery | A composite of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and the occurrence of new arrhythmias assessed within 4 months after CABG. | within 4months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience cardiovascular death within 4 months after surgery | Number of participants who experience cardiovascular death within 4 months after CABG | within 4months after surgery |
| Number of participants who experience nonfatal myocardial infarction within 4 months after surgery |
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Eligibility Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Joo Kim, Professor | Contact | +82-31-787-7855 | chorong24@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Seoul National University Bundang Hospital | Recruiting | Seongnam-si | 13620 | South Korea |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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|
Number of participants who experience nonfatal myocardial infarction within 4 months after CABG |
| within 4months after surgery |
| Number of participants who experience nonfatal stroke within 4 months after surgery | Number of participants who experience nonfatal stroke within 4 months after CABG | within 4months after surgery |
| Number of participants who experience new arrhythmia within 4 months after surgery | Number of participants who experience new arrhythmia within 4 months after CABG | within 4months after surgery |
| A composite of MACE within 1 year after surgery | A composite of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and the occurrence of new arrhythmias assessed within 1year after CABG | within 1 year after surgery |
| A composite of MACE within 5 year after surgery | A composite of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and the occurrence of new arrhythmias assessed within 5 years after CABG | within 5 years after surgery |
| All-cause mortality within 5 years after surgery | All-cause mortality within 5 years after surgery | within 5 years after surgery |
| Change in LVEF from baseline to 1 year after surgery | Left ventricular ejection fraction (LVEF) will be measured using transthoracic echocardiography at baseline (pre-operative) and at 1 year post-operatively. The outcome will be reported as the mean change in LVEF (%) from baseline to 1 year. | From baseline to 1 year after surgery |
| Change in LV EDD from baseline to 1 year after surgery | Left ventricular end-diastolic diameter (LVEDD) will be measured using transthoracic echocardiography at baseline (pre-operative) and at 1 year post-operatively. The outcome will be reported as the mean change in LVEDD (%) from baseline to 1 year. | From baseline to 1 year after surgery |
| Change in LV ESD from baseline to 1 year after surgery | Left ventricular end-systolic diameter (LV ESD) will be measured using transthoracic echocardiography at baseline (pre-operative) and at 1 year post-operatively. The outcome will be reported as the mean change in LV ESD (%) from baseline to 1 year. | From baseline to 1 year after surgery |
| Change in LVMI from baseline to 1 year after surgery | Left ventricular mass index (LVMI) will be measured using transthoracic echocardiography at baseline (pre-operative) and at 1 year post-operatively. The outcome will be reported as the mean change in LVMI (%) from baseline to 1 year. | From baseline to 1 year after surgery |
| Change in LAMI from baseline to 1 year after surgery | Left atrial volume index (LAMI) will be measured using transthoracic echocardiography at baseline (pre-operative) and at 1 year post-operatively. The outcome will be reported as the mean change in LAMI (%) from baseline to 1 year. | From baseline to 1 year after surgery |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |