NCT04087538

Brief Summary

The rising number of patients with chest pain without myocardial infarction has made accurate diagnosis important. Unnecessary invasive coronary angiographies are increasingly prevalent. These are both costly and lead to rare but serious adverse events. Recent studies suggest cardiac Troponin I is more cardiac specific than cardiac Troponin T. In this study we will investigate whether using cardiac Troponin I lead to fewer unnecessary procedures in clinical practice (i.e. invasive coronary angiography and non-invasive tests)

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

September 11, 2019

Last Update Submit

June 2, 2023

Conditions

Myocardial Infarction

Keywords

troponin

Outcome Measures

Primary Outcomes (2)

  • Specificity for MI

    The difference in specificity of cardiac Troponin and I in detecting patients with significant CAD. The specificity will be defined as the proportion of patients with no significant CAD on ICA correctly identified as low-risk patients and not referred to ICA upon the review by the senior cardiologists

    0

  • Cost-effectiveness

    The cost-effectiveness of using cardiac Troponin T compared to cardiac Troponin I. This will be defined by the number of patients sent to ICA and the associated costs of this.

    0

Secondary Outcomes (4)

  • Sensitivity for MI

    0

  • Elevated troponin without CAD

    0

  • Number of MIs

    0

  • PPV and NPV

    0

Study Arms (2)

Patients treated using troponin T

Diagnostic Test: Troponin T and I

Patients treated using troponin I

Diagnostic Test: Troponin T and I

Interventions

Troponin T and IDIAGNOSTIC_TEST

Does the use of troponin T or I increase the number of patients referred to coronary angiography

Patients treated using troponin IPatients treated using troponin T

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two large acute medical centers will include patients for this study, one that routinely use cTnT (Hvidovre Hospital) and one that routinely uses cTnI (Herlev Hospital). Each center will include consecutive patients over a period of 5 months clinically suspected of non-ST segment elevation myocardial infarction (NSTEMI). These patients will undergo serial measurement of either cardiac troponin T (cTnT) or cardiac troponin I (cTnI) as is standard practice. In addition to regular their lab tests, all patients will have extra blood samples set aside for a biobank. At the end of the inclusion period, all patients sent to invasive coronary angiography (ICA) will be identified and included in the further analyses. As one center uses cTnT and one uses cTnI, patients will have either biomarker measured upon admission. The other cTn assay will be measured on all samples from the biobank, so every patient has at least one measurement of both cTnT and cTnI.

You may qualify if:

  • Admitted to either Herlev-Gentofte or Amager-Hvidovre Hospital
  • Clinically suspected of NSTEMI
  • Referred to invasive coronary angiography (ICA)
  • Recieved at least one measurement of either troponin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bispebjerg Hospital

Bispebjerg, Copenhagen, 2400, Denmark

RECRUITING

Herlev-Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Kasper Iversen, Dmsc

CONTACT

28712753Kasper.karmark.iversen@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

July 1, 2021

Primary Completion

October 1, 2023

Study Completion

April 1, 2024

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations

DK(2)