Myocardial InfarctionNCT04087538
A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction
An observational study of Myocardial Infarction, run by Herlev Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Troponin T and I
- How many people
- 300 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jul 2021to 1 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Bispebjerg Hospital
Bispebjerg, Copenhagen, 2400
Olav Wendelboe Nielsen, +4531400200, olav.wendelboe.nielsen@regionh.dk
- Recruiting
Herlev-Gentofte Hospital
Herlev, 2730
Kasper Iversen, Dmsc, 28712753, Kasper.karmark.iversen@regionh.dk
About this study
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)
- Conditions
- Myocardial Infarction
- Being tested
- Troponin T and I
- Keywords
- troponin
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin T and IDiagnostic test
Does the use of troponin T or I increase the number of patients referred to coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Patients treated using troponin T | Not described Receives: Diagnostic Test: Troponin T and I | |
| Patients treated using troponin I | Not described Receives: Diagnostic Test: Troponin T and I |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 0
Secondary outcomes (4)
Sensitivity for MI
A safety outcome of difference in sensitivity of cardiac Troponin T and cardiac Troponin I in the detection of patients with significant coronary artery disease. The sensitivity is defined as the proportion of patients with significant coronary artery disease that were referred to ICA upon review by the senior cardiologists
Measured: 0
Elevated troponin without CAD
The difference in the proportion of patients with elevated cardiac Troponin T or cardiac Troponin I above the 99th percentile with no significant CAD on ICA
Measured: 0
Number of MIs
The difference in the number of patients diagnosed with MI for each cardiac Troponin
Measured: 0
PPV and NPV
The difference in positive predictive value and negative predictive value of each cardiac Troponin
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Jul 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Bo Hasselbalch, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087538
- Sponsor's protocol ID
- 19000557
- Status last verified
- Jun 2023
- First submitted
- 11 Sep 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04087538
- Acronym / sponsor ID
- 19000557
- Conditions
- Myocardial Infarction
- Keywords
- troponin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 12 Sep 2019 (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 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated using troponin T | – | Diagnostic Test: Troponin T and I |
| Patients treated using troponin I | – | Diagnostic Test: Troponin T and I |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Troponin T and IDoes the use of troponin T or I increase the number of patients referred to coronary angiography | Diagnostic test | Patients treated using troponin I, Patients treated using troponin T |
Primary outcome
Specificity for MI
Time frame: 0
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
Cost-effectiveness
Time frame: 0
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.
4 secondary outcomes
Sensitivity for MI
Time frame: 0
Elevated troponin without CAD
Time frame: 0
Number of MIs
Time frame: 0
PPV and NPV
Time frame: 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites 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, run by Herlev Hospital at 2 sites in Denmark.
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 1 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Kasper Iversen, Dmsc (28712753, Kasper.karmark.iversen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity for MI (time frame: 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2023.