Thyroid Hormone Replacement After Coronary Artery Bypass Grafting for Patients With Subclinical Hypothyroidism
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: levothyroxine.
- Кому может быть актуально
- Состояния в реестре: Subclinical Hypothyroidism. Базовые параметры: 19 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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: * Be randomly assigned to either receive levothyroxine or not * Start the medication one day before surgery if assigned to the treatment group. * Have regular follow-up visits to check thyroid function and cardiovascular events for up to five years after surgery.
Вмешательства
- Препарат levothyroxine
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.
Первичные конечные точки
- A composite of MACE within 4months after surgery [Срок оценки: within 4months after surgery]
Вторичные конечные точки (12)
- Number of participants who experience cardiovascular death within 4 months after surgery [Срок оценки: within 4months after surgery]
- Number of participants who experience nonfatal myocardial infarction within 4 months after surgery [Срок оценки: within 4months after surgery]
- Number of participants who experience nonfatal stroke within 4 months after surgery [Срок оценки: within 4months after surgery]
- Number of participants who experience new arrhythmia within 4 months after surgery [Срок оценки: within 4months after surgery]
- A composite of MACE within 1 year after surgery [Срок оценки: within 1 year after surgery]
- A composite of MACE within 5 year after surgery [Срок оценки: within 5 years after surgery]
- All-cause mortality within 5 years after surgery [Срок оценки: within 5 years after surgery]
- Change in LVEF from baseline to 1 year after surgery [Срок оценки: From baseline to 1 year after surgery]
- Change in LV EDD from baseline to 1 year after surgery [Срок оценки: From baseline to 1 year after surgery]
- Change in LV ESD from baseline to 1 year after surgery [Срок оценки: From baseline to 1 year after surgery]
- Change in LVMI from baseline to 1 year after surgery [Срок оценки: From baseline to 1 year after surgery]
- Change in LAMI from baseline to 1 year after surgery [Срок оценки: From baseline to 1 year after surgery]
Критерии участия
Eligibility Criteria
- Adults aged 19 to 90 years.
- Patients scheduled to undergo coronary artery bypass graft (CABG) surgery.
- Subclinical hypothyroidism (SCH), defined as a normal free thyroxine (free T4) level and a thyroid-stimulating hormone (TSH) level greater than 4 μIU/mL, based on testing performed within 31 days prior to surgery.
Критерии исключения
- Patients who underwent repeat or emergency CABG surgery
- Use of LT4 within the previous 4 weeks
- Use of antithyroid drug use (propylthiouracil, methimazole, or carbimazole) within the previous 3 months
- Severe comorbid conditions with a life expectancy of less than 1 year (e.g. advanced malignancy)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Department of Internal Medicine, Seoul National University Bundang Hospital — Seongnam-si
Идентификаторы
NCT: NCT07380854 · IRB-B-2110-717-003