Myocardial InfarctionSuperTROPONCT05858112
SuperTROPO (Better Diagnostics of Myocardial Infarction With a Test for Special Forms of Troponin)
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 110 years
- Conditions the study is for
- Myocardial Infarction, Myocardial Ischemia
- What is being tested?
- SuperTROPO novel assay to measure the long forms of cTnT
- How many people
- 3,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 May 2023to Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department and suspected with myocardial infarction
Who may be able to join
- 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
Who cannot join
- unable to give informed consent
- legally incompetent individuals
- pregnancy
- previously participated in this study
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku
Konsta Teppo, MD, PhD, 00358415027333
About this study
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Being tested
- SuperTROPO novel assay to measure the long forms of cTnT
- Keywords
- Troponin, Myocardial ischemia, Myocardial infarction, High-sensitivity troponin T
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperTROPO novel assay to measure the long forms of cTnTDiagnostic test
SuperTROPO novel assay to measure the long forms of cTnT
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected MI | Not described Receives: Diagnostic Test: SuperTROPO novel assay to measure the long forms of cTnT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction type 1
In brief, type 1 MI will be diagnosed when there is evidence of myocardial necrosis along with a clinical setting consistent with acute myocardial ischemia, as well as a coronary plaque rupture or erosion and superimposed thrombosis. The presence of the final diagnosis of type 1 MI by the treating clinician will be reviewed from patient records of the index hospitalization. Furthermore, patients with type 2 MI, will be identified and analyzed separately. The proportion of patients with type MI will be calculated and troponin values will be compared with patients with and without MI. .
Measured: During the index hospitalization, that is, the hospitalization after the drawn blood samples at the emergency department. Up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 May 2023
- Primary completionNov 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Saara Wittfooth, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858112
- Sponsor's protocol ID
- VARHA/487/13.02.02/2023
- Acronym
- SuperTROPO
- Status last verified
- Nov 2023
- First submitted
- 25 Apr 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Airaksinen KEJ, Teppo K, Vasankari T, Paana T, Junes H, Salonen S, Tuominen T, Simonen S, Strandberg M, Hellman T, Linko-Parvinen A, Pallari HM, Jaakkola S, Wittfooth S. Long Troponin T to Separate Troponin Elevations Among Patients With Atrial Fibrillation Versus Myocardial Infarction. J Am Heart Assoc. 2026 Mar 17;15(6):e044092. doi: 10.1161/JAHA.125.044092. Epub 2026 Feb 27.
PubMed 41757465
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SuperTROPO (Better Diagnostics of Myocardial Infarction With a Test for Special Forms of Troponin)
- ClinicalTrials.gov ID
- NCT05858112
- Acronym / sponsor ID
- SuperTROPO / VARHA/487/13.02.02/2023
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Keywords
- Troponin, Myocardial ischemia, Myocardial infarction, High-sensitivity troponin T
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 1 May 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected MI | – | Diagnostic Test: SuperTROPO novel assay to measure the long forms of cTnT |
Who may qualify
- Ages
- 19 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department and suspected with myocardial infarction
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- unable to give informed consent
- legally incompetent individuals
- pregnancy
- previously participated in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuperTROPO novel assay to measure the long forms of cTnTSuperTROPO novel assay to measure the long forms of cTnT | Diagnostic test | Patients with suspected MI |
Primary outcome
Myocardial infarction type 1
Time frame: During the index hospitalization, that is, the hospitalization after the drawn blood samples at the emergency department. Up to 12 weeks.
In brief, type 1 MI will be diagnosed when there is evidence of myocardial necrosis along with a clinical setting consistent with acute myocardial ischemia, as well as a coronary plaque rupture or erosion and superimposed thrombosis. The presence of the final diagnosis of type 1 MI by the treating clinician will be reviewed from patient records of the index hospitalization. Furthermore, patients with type 2 MI, will be identified and analyzed separately. The proportion of patients with type MI will be calculated and troponin values will be compared with patients with and without MI. .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 41757465Airaksinen KEJ, Teppo K, Vasankari T, Paana T, Junes H, Salonen S, Tuominen T, Simonen S, Strandberg M, Hellman T, Linko-Parvinen A, Pallari HM, Jaakkola S, Wittfooth S. Long Troponin T to Separate Troponin Elevations Among Patients With Atrial Fibrillation Versus Myocardial Infarction. J Am Heart Assoc. 2026 Mar 17;15(6):e044092. doi: 10.1161/JAHA.125.044092. Epub 2026 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konsta Teppo (00358415027333, jkitep@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarction type 1 (time frame: During the index hospitalization, that is, the hospitalization after the drawn blood samples at the emergency department. Up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05858112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.