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HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07726420
Acronym
MACRO-TROP
Enrollment
160
Registered
2026-07-24
Start date
2026-07-15
Completion date
2027-12-01
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnoses Disease

Keywords

troponin, athletes, polyethylene glycol precipitation

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTPolyethylene 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

DIAGNOSTIC_TESTTransthoracic 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.

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

There is no option to mask patients are investigators

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Recovery of troponin after polyethylene glycole precipitation in health and diseaseDay 1Comparison of polyethylene glycol recovery in athletes at rest and patients during acute coronary syndrome

Secondary

MeasureTime frameDescription
Recovery of troponin after polyethylene glycol precipitation after marathon runningDay 2Recovery of troponin after polyethlyene glycol will be assessed within one hour after completion of a marathon
Recovery of troponin after polyethylene glycole precipitation in patients with acute coronary syndrome upon hospital dischargeDay 2Recovery of troponin after polyethylene glycole precipitation within 24 hours before hospital discharge following treatment of acute coronary syndrome
Left and right ventricular ejection fraction in athletes at baselineDay 1Left and right ventricular ejection fraction in athletes at baseline
Left and right ventricular ejection fraction after marathon runningDay 2Left and right ventricular ejection fraction will be assessed with one hour after completion of a marathon
Left and right ventricular ejection fraction during acute coronary syndromeDay 1Left and right ventricular ejection fraction during acute presentation with acute coronary syndrome
Left and right ventricular ejection fraction after acute coronary syndromeDay 2Left and right ventricular ejection fraction after acute coronary syndrome, echocardiography will be performed within one day before hospital discharge

Countries

Germany

Contacts

CONTACTSimon Wernhart, MD, PhD
simon.wernhart@gmx.de+491751830099
CONTACTSebastian Zenk, MD
sebastian.zenk@synlab.com+49821227800
PRINCIPAL_INVESTIGATORSimon Wernhart, MD, PhD

TUM - Technische Universität München

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026