Technical University Munich
Munich, Bavaria, Germany
Location status: Recruiting
Location contact
Sebastian Zenk, MD
CONTACT
Simon Wernhart, MD, PhD
CONTACT
NCT Number: NCT07726420
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Munich, Bavaria, Germany
Location status: Recruiting
Sebastian Zenk, MD
CONTACT
Simon Wernhart, MD, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Day 1
Comparison of polyethylene glycol recovery in athletes at rest and patients during acute coronary syndrome
Time frame: Day 2
Recovery of troponin after polyethlyene glycol will be assessed within one hour after completion of a marathon
Time frame: Day 2
Recovery of troponin after polyethylene glycole precipitation within 24 hours before hospital discharge following treatment of acute coronary syndrome
Time frame: Day 1
Left and right ventricular ejection fraction in athletes at baseline
Time frame: Day 2
Left and right ventricular ejection fraction will be assessed with one hour after completion of a marathon
Time frame: Day 1
Left and right ventricular ejection fraction during acute presentation with acute coronary syndrome
Time frame: Day 2
Left and right ventricular ejection fraction after acute coronary syndrome, echocardiography will be performed within one day before hospital discharge
Contact information is provided by the study sponsor or research team.
Sebastian Zenk, MD
CONTACT
Simon Wernhart, MD, PhD
CONTACT
Technical University of Munich
Other
HEARTBEAT-TROP. Testing of Polyethylene Glycol Precipitation to Unmask Macrotroponin in Acute Coronary Syndrome and Marathon Runners.
Acronym: MACRO-TROP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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