HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin

NCT07726420 | Recruiting

• 1 other identifier: 2026-319-S-CT
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnoses Disease

Keywords

troponin; athletes; polyethylene glycol precipitation

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1

Secondary Outcomes (6)

• Recovery of troponin after polyethylene glycol precipitation after marathon running

  Day 2

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

  Day 2

• Left and right ventricular ejection fraction in athletes at baseline

  Day 1

• Left and right ventricular ejection fraction after marathon running

  Day 2

• Left and right ventricular ejection fraction during acute coronary syndrome

  Day 1

Study Arms (2)

Marathon runners

OTHER

Marathon runners are expected to have no elevated troponin at baseline after 24 hours of rest

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

Diagnostic Test: Polyethylene glycol precipitation; Diagnostic Test: Transthoracic echocardiography

Interventions

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

Marathon runners; Patients with acute coronary syndrome

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.

Marathon runners; Patients with acute coronary syndrome

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technical University Munich

Munich, Bavaria, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 37622654 BACKGROUND

• Stekelenburg 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.

  PMID: 41985028 BACKGROUND

• Salaun 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.

  PMID: 38879450 BACKGROUND

• Hammarsten 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.

  PMID: 36952681 BACKGROUND

• Hammarsten 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.

  PMID: 36889375 BACKGROUND

• Wernhart 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.

  PMID: 42253289 BACKGROUND

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Simon Wernhart, MD, PhD

  TUM - Technische Universität München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Wernhart, MD, PhD

CONTACT

+491751830099; simon.wernhart@gmx.de

Sebastian Zenk, MD

CONTACT

+49821227800; sebastian.zenk@synlab.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: There is no option to mask patients are investigators
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 24, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Information will be made available upon reasonable request starting from 01.01.2028 until 31.12.2028.
• Access Criteria: Direct contact to the principal investigator will be needed.

Locations

DE (1)