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

NCT ID: NCT05858112

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with suspected MI

SuperTROPO novel assay to measure the long forms of cTnT

Intervention Type DIAGNOSTIC_TEST

SuperTROPO novel assay to measure the long forms of cTnT

Interventions

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SuperTROPO novel assay to measure the long forms of cTnT

SuperTROPO novel assay to measure the long forms of cTnT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Saara Wittfooth

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Konsta Teppo

Role: CONTACT

00358415027333

Facility Contacts

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Konsta Teppo, MD, PhD

Role: primary

00358415027333

Other Identifiers

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VARHA/487/13.02.02/2023

Identifier Type: -

Identifier Source: org_study_id