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HEARTBEAT-TROP. Polyethylene Glycol Precipitation to Unmask Macrotroponin

ConditionDiagnoses Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnical University of Munich

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Marathon runnersOther 2 interventions
Group B: Patients with acute coronary syndromeOther 2 interventions

Trial outcomes

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

Time frame
Day 1

Secondary outcomes

1

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

Time frame
Day 2
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

Time frame
Day 2
3

Left and right ventricular ejection fraction in athletes at baseline

Left and right ventricular ejection fraction in athletes at baseline

Time frame
Day 1
4

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

Time frame
Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technical University of Munich

Lead sponsor

Source ClinicalTrials.gov
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