Diagnoses DiseaseMACRO-TROPNCT07726420
HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin
A study testing Polyethylene glycol precipitation and Transthoracic echocardiography in people with Diagnoses Disease, run by Technical University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- Polyethylene glycol precipitation and Transthoracic echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jul 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Technical University Munich
Munich, Bavaria
Simon Wernhart, MD, PhD, +491751830099, simon.wernhart@gmx.de
Sebastian Zenk, MD, +49821227800, sebastian.zenk@synlab.com
About this study
Official title: HEARTBEAT-TROP. Testing of Polyethylene Glycol Precipitation to Unmask Macrotroponin in Acute Coronary Syndrome and Marathon Runners.
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.
Read the detailed description
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.
- Conditions
- Diagnoses Disease
- Being tested
- Polyethylene glycol precipitation, Transthoracic echocardiography
- Keywords
- troponin, athletes, polyethylene glycol precipitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene glycol precipitationDiagnostic 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 echocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Marathon runners | Other | Marathon runners are expected to have no elevated troponin at baseline after 24 hours of rest Receives: Diagnostic Test: Polyethylene glycol precipitation; Diagnostic Test: Transthoracic echocardiography |
| Patients with acute coronary syndrome | Other | Troponin will be elevated in acute coronary syndrome per definition Receives: Diagnostic Test: Polyethylene glycol precipitation; Diagnostic Test: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of troponin after polyethylene glycole precipitation in health and disease
Comparison of polyethylene glycol recovery in athletes at rest and patients during acute coronary syndrome
Measured: Day 1
Secondary outcomes (6)
Recovery of troponin after polyethylene glycol precipitation after marathon running
Recovery of troponin after polyethlyene glycol will be assessed within one hour after completion of a marathon
Measured: Day 2
Recovery of troponin after polyethylene glycole precipitation in patients with acute coronary syndrome upon hospital discharge
Recovery of troponin after polyethylene glycole precipitation within 24 hours before hospital discharge following treatment of acute coronary syndrome
Measured: Day 2
Left and right ventricular ejection fraction in athletes at baseline
Left and right ventricular ejection fraction in athletes at baseline
Measured: Day 1
Left and right ventricular ejection fraction after marathon running
Left and right ventricular ejection fraction will be assessed with one hour after completion of a marathon
Measured: Day 2
Left and right ventricular ejection fraction during acute coronary syndrome
Left and right ventricular ejection fraction during acute presentation with acute coronary syndrome
Measured: Day 1
Left and right ventricular ejection fraction after acute coronary syndrome
Left and right ventricular ejection fraction after acute coronary syndrome, echocardiography will be performed within one day before hospital discharge
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups are analyzed: (1) Patients presenting with acute coronary syndrome and undergoing invasive coronary angiography. (2) Healthy athletes cleared through pre-participation screening and participating in a marathon.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Dr. rer. nat. Simon Wernhart, Technical University of Munich
- Investigators
- Simon Wernhart, MD, PhD, Principal investigator, TUM - Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726420
- Sponsor's protocol ID
- 2026-319-S-CT
- Acronym
- MACRO-TROP
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon reasonable request and adherence to national data security policy
Publications
Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654Stekelenburg JO, Berge K, Janssen SLJE, Omland T, Myhre PL, Thompson PD, Aengevaeren VL, Eijsvogels TMH. Prevalence and Predictors of Cardiac Troponin Elevations Following Exercise: a Systematic Review, Meta-analysis, and Meta-regression. Eur J Prev Cardiol. 2026 Apr 15:zwag218. doi: 10.1093/eurjpc/zwag218. Online ahead of print.
PubMed 41985028Salaun E, Drory S, Cote MA, Tremblay V, Bedard E, Steinberg C, Pare D, O'Connor K, Cieza T, Cote N, Poirier P, Douville P, Blais J, Desmeules P, Kalavrouziotis D, Mohammadi S, Voisine P, Bernier M, Pibarot P, Theriault S. Role of Antitroponin Antibodies and Macrotroponin in the Clinical Interpretation of Cardiac Troponin. J Am Heart Assoc. 2024 Jun 18;13(12):e035128. doi: 10.1161/JAHA.123.035128. Epub 2024 Jun 15.
PubMed 38879450Hammarsten O, Warner JV, Lam L, Kavsak P, Lindahl B, Aakre KM, Collinson P, Jaffe AS, Saenger AK, Body R, Mills NL, Omland T, Ordonez-Llanos J, Apple FS. Antibody-mediated interferences affecting cardiac troponin assays: recommendations from the IFCC Committee on Clinical Applications of Cardiac Biomarkers. Clin Chem Lab Med. 2023 Mar 24;61(8):1411-1419. doi: 10.1515/cclm-2023-0028. Print 2023 Jul 26.
PubMed 36952681Hammarsten O, Becker C, Engberg AE. Methods for analyzing positive cardiac troponin assay interference. Clin Biochem. 2023 Jun;116:24-30. doi: 10.1016/j.clinbiochem.2023.03.004. Epub 2023 Mar 6.
PubMed 36889375Wernhart S, Halle M, Zenk S. Handling persistent cardiac troponin elevation in asymptomatic athletes: The role of macrocomplexes. Am Heart J Plus. 2026 May 25;67:100804. doi: 10.1016/j.ahjo.2026.100804. eCollection 2026 Jul.
PubMed 42253289
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEARTBEAT-TROP. Testing of Polyethylene Glycol Precipitation to Unmask Macrotroponin in Acute Coronary Syndrome and Marathon Runners.
- ClinicalTrials.gov ID
- NCT07726420
- Acronym / sponsor ID
- MACRO-TROP / 2026-319-S-CT
- Conditions
- Diagnoses Disease
- Keywords
- troponin, athletes, polyethylene glycol precipitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups are analyzed: (1) Patients presenting with acute coronary syndrome and undergoing invasive coronary angiography. (2) Healthy athletes cleared through pre-participation screening and participating in a marathon.
| Arm | Type | Receives |
|---|---|---|
| Marathon runners | Other | Diagnostic Test: Polyethylene glycol precipitation, Diagnostic Test: Transthoracic echocardiographyMarathon runners are expected to have no elevated troponin at baseline after 24 hours of rest |
| Patients with acute coronary syndrome | Other | Diagnostic Test: Polyethylene glycol precipitation, Diagnostic Test: Transthoracic echocardiographyTroponin will be elevated in acute coronary syndrome per definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyethylene glycol precipitationPEG 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 | Diagnostic test | Marathon runners, Patients with acute coronary syndrome |
| Transthoracic echocardiographyPatients 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. | Diagnostic test | Marathon runners, Patients with acute coronary syndrome |
Primary outcome
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
6 secondary outcomes
Recovery of troponin after polyethylene glycol precipitation after marathon running
Time frame: Day 2
Recovery of troponin after polyethylene glycole precipitation in patients with acute coronary syndrome upon hospital discharge
Time frame: Day 2
Left and right ventricular ejection fraction in athletes at baseline
Time frame: Day 1
Left and right ventricular ejection fraction after marathon running
Time frame: Day 2
Left and right ventricular ejection fraction during acute coronary syndrome
Time frame: Day 1
Left and right ventricular ejection fraction after acute coronary syndrome
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
- Background: PubMed 41985028Stekelenburg JO, Berge K, Janssen SLJE, Omland T, Myhre PL, Thompson PD, Aengevaeren VL, Eijsvogels TMH. Prevalence and Predictors of Cardiac Troponin Elevations Following Exercise: a Systematic Review, Meta-analysis, and Meta-regression. Eur J Prev Cardiol. 2026 Apr 15:zwag218. doi: 10.1093/eurjpc/zwag218. Online ahead of print.
- Background: PubMed 38879450Salaun E, Drory S, Cote MA, Tremblay V, Bedard E, Steinberg C, Pare D, O'Connor K, Cieza T, Cote N, Poirier P, Douville P, Blais J, Desmeules P, Kalavrouziotis D, Mohammadi S, Voisine P, Bernier M, Pibarot P, Theriault S. Role of Antitroponin Antibodies and Macrotroponin in the Clinical Interpretation of Cardiac Troponin. J Am Heart Assoc. 2024 Jun 18;13(12):e035128. doi: 10.1161/JAHA.123.035128. Epub 2024 Jun 15.
- Background: PubMed 36952681Hammarsten O, Warner JV, Lam L, Kavsak P, Lindahl B, Aakre KM, Collinson P, Jaffe AS, Saenger AK, Body R, Mills NL, Omland T, Ordonez-Llanos J, Apple FS. Antibody-mediated interferences affecting cardiac troponin assays: recommendations from the IFCC Committee on Clinical Applications of Cardiac Biomarkers. Clin Chem Lab Med. 2023 Mar 24;61(8):1411-1419. doi: 10.1515/cclm-2023-0028. Print 2023 Jul 26.
- Background: PubMed 36889375Hammarsten O, Becker C, Engberg AE. Methods for analyzing positive cardiac troponin assay interference. Clin Biochem. 2023 Jun;116:24-30. doi: 10.1016/j.clinbiochem.2023.03.004. Epub 2023 Mar 6.
- Background: PubMed 42253289Wernhart S, Halle M, Zenk S. Handling persistent cardiac troponin elevation in asymptomatic athletes: The role of macrocomplexes. Am Heart J Plus. 2026 May 25;67:100804. doi: 10.1016/j.ahjo.2026.100804. eCollection 2026 Jul.
- Individual participant dataSharing planned: Yes. Data will be provided upon reasonable request and adherence to national data security policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon Wernhart, MD, PhD principal investigator
TUM - Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene glycol precipitation and Transthoracic echocardiography in people with Diagnoses Disease, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Wernhart, MD, PhD (+491751830099, simon.wernhart@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of troponin after polyethylene glycole precipitation in health and disease (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726420, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.