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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Myocardial Ischemia
• Intervention / Treatment: Diagnostic test: SuperTROPO novel assay to measure the long forms of cTnT

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Konsta Teppo; Phone Number: 00358415027333; Email: jkitep@utu.fi

Study Locations

• Finland
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Konsta Teppo, MD, PhD; Phone Number: 00358415027333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department and suspected with myocardial infarction

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with suspected MI	Diagnostic test: SuperTROPO novel assay to measure the long forms of cTnT; SuperTROPO novel assay to measure the long forms of cTnT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. .	During the index hospitalization, that is, the hospitalization after the drawn blood samples at the emergency department. Up to 12 weeks.

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Myocardial infarction; Myocardial ischemia; Troponin; High-sensitivity troponin T
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: VARHA/487/13.02.02/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No