Clinical trial NCT05858112: SuperTROPO (Better Diagnostics of Myocardial Infarction With a Test for Special Forms of Troponin)
Official title: SuperTROPO (Better Diagnostics of Myocardial Infarction With a Test for Special Forms of Troponin)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Myocardial Ischemia
Keywords: Troponin
Myocardial ischemia
Myocardial infarction
High-sensitivity troponin T
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2023-05-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department and suspected with myocardial infarction

Brief summary: The aim of this study is to investigate whether measurement of the long forms of cTnT with the novel SuperTROPO assay would improve the diagnosis of myocardial infarction in patients in the emergency department. The main goals are:

1. To assess whether measuring long forms of cTnT with the novel SuperTROPO assay and determining the ratio of long cTnT and standard high-sensitivity cTnT could separate patients with type 1 NSTEMI patients from patients with other causes of minor (\> 14ng/L) cTnT elevation in a single admission blood sample in unselected emergency department patients with clinical indication for troponin measurement.
2. To compare the level of long cTnT and the ratio of long cTnT and standard cTnT in patients with type 1 MI and various clinical patient groups admitted to emergency department with elevated standard cTnT, e.g. patients with atrial fibrillation, heart failure or renal impairment.
3. To evaluate optimal cut-off values for long cTnT and its ratio to standard cTnT in the exclusion and diagnosis of MI in a clinical setting with elevated (\>14ng/L) cTnT.
4. To evaluate how time from symptom onset and peak symptom to blood sampling, as well as comorbidities and patients' age impact the discriminative capacity of long cTnT and cTnT ratio between patients with and without type 1 MI.
5. To investigate whether information on long cTnT and its ratio to standard cTnT can be used to cut down unnecessary coronary angiographies and hospital admissions

The long forms of cTnT are measured from the residual blood samples routinely collected from patients with suspected myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Patient has arrived at the emergency department and high-sensitivity cTnT test (P-TnT) has been ordered as part of the routine "cardiac package" of laboratory tests upon arrival
* Result of \>14 ng/L of the P-TnT test included in the "cardiac package"
* Age \> 18
* The patient or his/her legal representative has given written informed consent for participation in the study

Exclusion Criteria:

* unable to give informed consent
* legally incompetent individuals
* pregnancy
* previously participated in this study

Primary outcomes:
measure: Myocardial infarction type 1
timeFrame: During the index hospitalization, that is, the hospitalization after the drawn blood samples at the emergency department. Up to 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: