HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin

Официальное название

HEARTBEAT-TROP. Testing of Polyethylene Glycol Precipitation to Unmask Macrotroponin in Acute Coronary Syndrome and Marathon Runners.

Обзор

Troponin elevation can, among others, be due to myocardial infarction, acute inflammation or structural heart disease. Formation of macrocomplexes against troponin is an underestimated cause for persistent troponin elevation. Polyethlylene glycol precipitation (PEG) can differentiate macrotroponin from real troponin elevation, but cut-off values for PEG have not been established. PEG is analyzed in patients with acute coronary syndrome undergoing invasive coronary angiography and compared to healthy marathon runners who have undergone cardiological pre-participation screening and have rested for 24 hours.

Подробное описание

Troponin elevation can be caused by acute coronary syndrome, myocarditis or structural heart disease. In most cases, troponin levels drop back to normal after the acute phase of the disease. In some cases, troponin elevation may persist despite clinical recovery due to macrocomplex formation. In athletes, this may cause unnecessary exclusion from competitive sport. Polypethylene glycol precipitation (PEG) has emerged as a cost-effective and feasible laboratory method to reveal macrotroponin. However, cut-off values have not been established for macrotroponin. PEG will be assessed in patients presenting with acute coronary syndrome (ACS) and undergoing invasive coronary angiography and compared to healthy controls, marathon runners who have undergone cardiological pre-participation screening and have been cleared for competition. 24 hours of rest are required before troponin levels are assessed in these athletes. In the control group of marathon runners, PEG will also be analyzed within one hour after crossing the finishing line. In both groups, blood lipids (LDL-cholesterol, lipoprotein a), blood glucose and hemoglobin 1Ac will be assessed at baseline. Transthoracic echocardiography will be performed in both groups at baseline. Also, in the marathon group echocardiography will be performed within one hour after completion of the race. PEG and echocardiography will also be repeated in the group of ACS within 24 hours before hospital discharge. The primary outcome is PEG recovery in both groups at presentation (upon emergency presentation in ACS and baseline examination in athletes). Secondary outcomes are PEG recovery values in the second exam (before discharge in ACS and within one hour after marathon completion in athletes), left and right ventricular ejection fraction in both groups during both exams. Athletes are defined as marathon participants older than 18 years without overt cardiovascular disease.

Вмешательства

• Диагностический тест Polyethylene glycol precipitation
  PEG will be assessed in patients with acute coronary syndrome upon presentation and before hospital discharge. Athletes will receive this intervention at baseline and within one hour after completion of the marathon
• Диагностический тест Transthoracic echocardiography
  Patients with acute coronary syndrome will receive echocardiography upon presentation and before hospital discharge. Athletes will receive echocardiography at baseline and within one after marathon completion.

Первичные конечные точки

• Recovery of troponin after polyethylene glycole precipitation in health and disease [Срок оценки: Day 1]

Вторичные конечные точки (6)

• Recovery of troponin after polyethylene glycol precipitation after marathon running [Срок оценки: Day 2]
• Recovery of troponin after polyethylene glycole precipitation in patients with acute coronary syndrome upon hospital discharge [Срок оценки: Day 2]
• Left and right ventricular ejection fraction in athletes at baseline [Срок оценки: Day 1]
• Left and right ventricular ejection fraction after marathon running [Срок оценки: Day 2]
• Left and right ventricular ejection fraction during acute coronary syndrome [Срок оценки: Day 1]
• Left and right ventricular ejection fraction after acute coronary syndrome [Срок оценки: Day 2]

Критерии участия

Критерии включения

• Age above 18 years
• Group with acute coronary syndrome (ACS): Diagnosis of ACS (ST-segment elevation or non-ST-segment elevation myocardial infarction according to the European Society of Cardiology Guidelines 2023 with at least one measurement of high sensitive troponin I or T above the 99th percentile of reference).
• Marathon runners: Participation in a marathon following cardiological pre-participation screening and medical clearance for competition. No clinical signs of cardiovascular or structural heart disease

Критерии исключения

• Patients with acute coronary syndrome: Known macrotroponin, terminal renal disease (glomerular filtration rate below 10ml per minute), diagnosis of cancer, pregnancy
• Marathon runners: Coronary artery disease, structural heart disease, diagnosis of cancer, pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Германия · 1 центр

• Technical University Munich — Munich

Публикации

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Идентификаторы

NCT: NCT07726420 · 2026-319-S-CT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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