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NCT Number: NCT07726420

HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Polyethylene glycol precipitation

Diagnostic Test

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

Transthoracic echocardiography

Diagnostic Test

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.

Primary outcomes

  1. Recovery of troponin after polyethylene glycole precipitation in health and disease

    Time frame: Day 1

    Comparison of polyethylene glycol recovery in athletes at rest and patients during acute coronary syndrome

Secondary outcomes

  1. Recovery of troponin after polyethylene glycol precipitation after marathon running

    Time frame: Day 2

    Recovery of troponin after polyethlyene glycol will be assessed within one hour after completion of a marathon

  2. Recovery of troponin after polyethylene glycole precipitation in patients with acute coronary syndrome upon hospital discharge

    Time frame: Day 2

    Recovery of troponin after polyethylene glycole precipitation within 24 hours before hospital discharge following treatment of acute coronary syndrome

  3. Left and right ventricular ejection fraction in athletes at baseline

    Time frame: Day 1

    Left and right ventricular ejection fraction in athletes at baseline

  4. Left and right ventricular ejection fraction after marathon running

    Time frame: Day 2

    Left and right ventricular ejection fraction will be assessed with one hour after completion of a marathon

  5. Left and right ventricular ejection fraction during acute coronary syndrome

    Time frame: Day 1

    Left and right ventricular ejection fraction during acute presentation with acute coronary syndrome

  6. Left and right ventricular ejection fraction after 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Zenk, MD

CONTACT

[email protected]

+49821227800

Simon Wernhart, MD, PhD

CONTACT

[email protected]

+491751830099

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: MACRO-TROP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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