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SuperTROPO (Better Diagnostics of Myocardial Infarction With a Test for Special Forms of Troponin)

T

Turku University Hospital (TYKS)

Status

Enrolling

Conditions

Myocardial Ischemia
Myocardial Infarction

Treatments

Diagnostic Test: SuperTROPO novel assay to measure the long forms of cTnT

Study type

Observational

Funder types

Other

Identifiers

NCT05858112
VARHA/487/13.02.02/2023

Details and patient eligibility

About

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.

Enrollment

3,000 estimated patients

Sex

All

Ages

19 to 110 years old

Volunteers

No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Patients with suspected MI
Treatment:
Diagnostic Test: SuperTROPO novel assay to measure the long forms of cTnT

Trial contacts and locations

1

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Central trial contact

Konsta Teppo

Data sourced from clinicaltrials.gov

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