- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07726420
HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin (MACRO-TROP)
22. juli 2026 opdateret af: PD Dr. med. Dr. rer. nat. Simon Wernhart, Technical University of Munich
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Simon Wernhart, MD, PhD
- Telefonnummer: +491751830099
- E-mail: simon.wernhart@gmx.de
Undersøgelse Kontakt Backup
- Navn: Sebastian Zenk, MD
- Telefonnummer: +49821227800
- E-mail: sebastian.zenk@synlab.com
Studiesteder
-
-
Bavaria
-
Munich, Bavaria, Tyskland
- Rekruttering
- Technical University Munich
-
Kontakt:
- Simon Wernhart, MD, PhD
- Telefonnummer: +491751830099
- E-mail: simon.wernhart@gmx.de
-
Kontakt:
- Sebastian Zenk, MD
- Telefonnummer: +49821227800
- E-mail: sebastian.zenk@synlab.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Marathon runners
Marathon runners are expected to have no elevated troponin at baseline after 24 hours of rest
|
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.
|
|
Andet: Patients with acute coronary syndrome
Troponin will be elevated in acute coronary syndrome per definition
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recovery of troponin after polyethylene glycole precipitation in health and disease
Tidsramme: Day 1
|
Comparison of polyethylene glycol recovery in athletes at rest and patients during acute coronary syndrome
|
Day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recovery of troponin after polyethylene glycol precipitation after marathon running
Tidsramme: Day 2
|
Recovery of troponin after polyethlyene glycol will be assessed within one hour after completion of a marathon
|
Day 2
|
|
Recovery of troponin after polyethylene glycole precipitation in patients with acute coronary syndrome upon hospital discharge
Tidsramme: Day 2
|
Recovery of troponin after polyethylene glycole precipitation within 24 hours before hospital discharge following treatment of acute coronary syndrome
|
Day 2
|
|
Left and right ventricular ejection fraction in athletes at baseline
Tidsramme: Day 1
|
Left and right ventricular ejection fraction in athletes at baseline
|
Day 1
|
|
Left and right ventricular ejection fraction after marathon running
Tidsramme: Day 2
|
Left and right ventricular ejection fraction will be assessed with one hour after completion of a marathon
|
Day 2
|
|
Left and right ventricular ejection fraction during acute coronary syndrome
Tidsramme: Day 1
|
Left and right ventricular ejection fraction during acute presentation with acute coronary syndrome
|
Day 1
|
|
Left and right ventricular ejection fraction after acute coronary syndrome
Tidsramme: Day 2
|
Left and right ventricular ejection fraction after acute coronary syndrome, echocardiography will be performed within one day before hospital discharge
|
Day 2
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Simon Wernhart, MD, PhD, TUM - Technische Universität München
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
18. juli 2026
Først indsendt, der opfyldte QC-kriterier
22. juli 2026
Først opslået (Faktiske)
24. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-319-S-CT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Data will be provided upon reasonable request and adherence to national data security policy
IPD-delingstidsramme
Information will be made available upon reasonable request starting from 01.01.2028 until 31.12.2028.
IPD-delingsadgangskriterier
Direct contact to the principal investigator will be needed.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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