None listed
Conditions
Brief summary
Troponin blood tests are essential for diagnosing heart attacks, but in some people the results can appear falsely elevated because of laboratory interference such as macrotroponin, even when there is no true heart damage. Macrotroponin is an under-recognised condition where troponin binds to other proteins in the blood, leading to persistently high troponin levels that may result in unnecessary hospital admissions, investigations, and anxiety. This study focuses on patients with suspected Myocardial Infarction with Non-Obstructive Coronary Arteries and ongoing elevated troponin levels, where test interference may be mistaken for genuine heart injury. Around 200 participants will undergo additional blood testing using different troponin assays and complete short health questionnaires to determine how often macrotroponin occurs and its clinical impact. The findings may improve recognition of false-positive troponin results and help reduce unnecessary procedures, healthcare costs, and patient distress in the future.
Interventions
This study aims to systematically assess the prevalence, clinical and economic impacts of troponin assay interference i.e macrotroponin in patients with a presumed diagnosis of MINOCA and static troponin elevations.
This is a single-centre, prospective observational cohort study conducted at the Royal Melbourne Hospital.
Participants will be identified retrospectively via electronic medical record (EMR) and pathology database screening (2021–2027) and prospectively recalled for a single study vi
This study aims to systematically assess the prevalence, clinical and economic impacts of troponin assay interference i.e macrotroponin in patients with a presumed diagnosis of MINOCA and static troponin elevations. This is a single-centre, prospective observational cohort study conducted at the Royal Melbourne Hospital. Participants will be identified retrospectively via electronic medical record (EMR) and pathology database screening (2021–2027) and prospectively recalled for a single study visit involving confirmatory troponin testing and survey completion. The study does not involve any investigational treatment or alteration to standard clinical care. Prospective recall with alternative troponin assay (Alinity Troponin I, Vitros Troponin I and Roche Troponin T) to test for interference. Polyethylene glycol (PEG) testing provides direct confirmation of macrotroponin to provide a precise prevalence estimate (primary aim). All blood samples will be collected in person at a Royal Melbourne Hospital outpatient pathology collection centre. Electronic medical record linkage will facilitate ascertainment of major adverse cardiovascular events (MACE), healthcare utilisation, and healthcare costs. Participants will complete the MacNew Quality of Life After Myocardial Infarction questionnaire, providing assessment of quality of life and psychological impact as secondary study outcomes. The questionnaire requires approximately 20 minutes to complete and can be administered via telehealth or through a secure REDCap platform according to participant preference. Blood samples will be collected and initially processed locally before undergoing batched laboratory analysis.. Roche high-sensitivity troponin T testing and PEG precipitation assays will be performed in batches rather than immediately following sample collection. Testing is anticipated to be completed in approximately two weeks, after which results will be reviewed and classified as consistent or inconsistent with macrotroponin interference.
Sponsors
Royal Melbourne Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults 18 years and over • Non-dynamic troponin kinetics defined as less than 20% rise and fall • Patients suspected to have troponin assay interferences • Underwent invasive coronary angiography or CT coronary angiogram between 2021–2027 which revealed non-obstructive coronary artery disease (defined as <50% stenosis)
Exclusion criteria
• Previously confirmed assay interefences i.e macrotroponin • Chronic kidney disease (CKD) stage 5 • Troponin elevation >50,000 ng/L • Recent coronary revascularisation • Significant coronary artery disease (CAD) medically managed due to comorbidities • Arrhythmia-related myocardial infarction (MI) • Type 2 MI from sepsis, pulmonary embolism and myocarditis, non-cardiac surgery.
Outcome results
None listed