A comparison of the utility of a new cardiac biomarker, cardiac myosin-binding protein C, with the exisiting gold standard cardiac biomarker, troponin, in the early assessment of patients presenting to the Emergency Department with symptoms suspicious for heart attack.

The utility of cardiac myosin-binding protein C in the early triage of patients with suspected acute coronary syndromes.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001246178

Acronym

ULYCES

Enrollment

528

Registered

2019-09-09

Start date

2020-03-11

Completion date

2021-12-14

Last updated

2023-02-20

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

Conditions

None listed

Brief summary

Acute chest pain is a common reason for patients to present to an Emergency Department (ED). The majority (>75%) of these individuals are at low risk of serious complications, with only a small proportion diagnosed with an acute coronary syndrome (ACS) or other major pathology. The consequences of misdiagnosis are, however, potentially catastrophic. Thus, considerable time and resources are expended to ensure the accurate triage of such patients. Currently, high sensitivity troponin (hsTn) is used to aid in the diagnosis of ACS. However, in patients presenting early (i.e. <2 hrs) after the onset of their symptoms, hsTn may not yet have been released in great enough quantities to be detected. This may result in a treatment delay for some patients. Recently a new biomarker, cardiac myosin-binding protein C (cMyC) has been identified that rises more rapidly than hsTn in patients with ACS. Our aim will be to compare the utility of cMyC with hsTnI in the early assessment of low risk patients presenting to the ED with chest pain. We anticipate that because serum cMyC levels rise more quickly than hsTnI, this new assay will be most useful in patients who present soon after the onset of symptoms.

Interventions

Methods/Research Plan: Design, strategy and framework: The ULYCES study will test the clinical utility of cMyC in a subset of ~2,000 consecutive patients who present to RPH with symptoms suspicious for ACS. It will be a prospective, quantitative, observational trial. All blood samples gathered will form an “ACS biobank” which will be used for this research study, and may be used in the future for further research into new biomarkers after appropriate human research ethics approval. Patients will be recruited from the Royal Perth Hospital Emergency department from Monday to Friday during business hours. All patients presenting with symptoms suspicious for an acute coronary syndrome will be screened for enrolment. We aim to recruit approximately 1500-2000 patients. Based on prior data we expect it will take less than 6 months to recruit this number of patients. Blood samples: Blood samples will be collected at presentation to the ED (0 h) and, in patients who require serial sampling according to established treatment protocols, after 2 hours as part of routine care. These blood samples will be used by treating doctors to make decisions about their care. We will also gather an additional blood sample at 1hr after arrival in the emergency department, which will be used for research purposes only. Baseline clinical data will be routinely collected using a standardised proforma. This will include the times of symptom onset and blood collection. The samples of participants in the ULYCES study will be ‘biobanked’ by the PathWest laboratory at Royal Perth Hospital and stored at -80oC. High sensitivity cTnI will be measured on the same samples as part of routine clinical care. cMyC will be measured on batched samples using a high-sensitivity assay developed by Millipore Sigma (Hayward, California). Residual sample will be kept for additional research studies, with appropriate ethical approval.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult patients (greater than or equal to 18 years old), presenting to the ED of Royal Perth Hospital with symptoms suspicious of ACS; defined as >5 minutes of acute symptoms in the past 12 hours potentially caused by myocardial ischaemia, in accordance with the AHA definitions (acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure without a clear non-cardiac source)

Exclusion criteria

Patients < 18 years old; patients with an ST-elevation MI; patients with a clear non-cardiac cause of chest pain and/or no indication for troponin measurement; patients requiring hospital admission for reasons apart from chest pain (e.g. other medical problems requiring admission and investigation); Patients with ongoing symptoms requiring hospitalisation for symptom relief.

Outcome results