Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
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: data collection from the hospital records.
- Кому может быть актуально
- Состояния в реестре: Coronary Bypass Graft Occlusion. Базовые параметры: от 18 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
- Хорватия, Польша, Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.
Подробное описание
The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.
Вмешательства
- Другое data collection from the hospital records
The clinical data from the patients enrolled in the study, such as the medical history, functional state, and EuroSCORE, and the hematological, basic renal, hepatic, and metabolic chemistry findings (including cTn as defined per the protocol), the operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts, the number of distal anastomoses, flow measured at all bypass grafts at the end of the intervention and the need for an assist devic
Первичные конечные точки
- Change in hs-cTn level (ng/L) [Срок оценки: Day 0 to discharge date (max 10 days)]
Вторичные конечные точки (6)
- All-cause mortality during hospital stay (death before discharge) [Срок оценки: Day 0 to discharge date (max 10 days)]
- Cardiac-related mortality during hospital stay [Срок оценки: Day 0 to discharge date (max 10 days)]
- Myocardial infarction during hospital stay [Срок оценки: Day 0 to discharge date (max 10 days)]
- Surgical or percutaneous coronary re-intervention during hospital stay [Срок оценки: Day 0 to discharge date (max 10 days)]
- Stroke rate during hospital stay [Срок оценки: Day 0 to discharge date (max 10 days)]
- Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay [Срок оценки: Day 0 to discharge date (max 10 days)]
Критерии участия
Критерии включения
- patients with isolated coronary bypass surgery
Критерии исключения
- Patients withholding or lacking informed consent
- Patients requiring a concomitant procedure
- Exclusion criteria concerning the CCT scan
- Patients with known allergy to iodine-containing contrast agents
- Renal function impairment (serum creatinine >140 mmol/l; estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
- Pregnancy
- Unstable clinical state or severe heart failure
- Patients with registered MI and registered bypass occlusion in coronary angiogram
- Patients that didn't undergo a CCT prior to discharge
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Хорватия · 1 центр
- University Hospital Centre Zagreb — Zagreb
Польша · 1 центр
- Wroclaw Medical University — Wroclaw
Швейцария · 1 центр
- Department for Cardiac Surgery, University Hospital Basel — Basel
Публикации
- Salikhanov I, Koechlin L, Gahl B, Voehringer L, Reuthebuch O, Dimanski D, Mawad BM, Berdajs D. Survival, adverse events and management of silent in-hospital coronary bypass graft occlusion. Open Heart. 2025 Jul 7;12(2):e003368. doi: 10.1136/openhrt-2025-003368. PMID 40623893
Идентификаторы
NCT: NCT04595630 · 2020-02257; ch20Berdajs