NCT05858112

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. 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. 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. 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. 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

April 25, 2023

Last Update Submit

November 21, 2023

Conditions

Myocardial InfarctionMyocardial Ischemia

Keywords

TroponinMyocardial ischemiaMyocardial infarctionHigh-sensitivity troponin T

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Patients with suspected MI

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

Interventions

SuperTROPO novel assay to measure the long forms of cTnTDIAGNOSTIC_TEST

SuperTROPO novel assay to measure the long forms of cTnT

Patients with suspected MI

Eligibility Criteria

Age19 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department and suspected with myocardial infarction

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leftover plasma from the blood samples collected routinely at the emergency department

MeSH Terms

Conditions

Myocardial InfarctionMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Konsta Teppo

CONTACT

00358415027333jkitep@utu.fi

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 15, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2025

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)