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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated using troponin T |
| ||
| Patients treated using troponin I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Troponin T and I | Diagnostic Test | Does the use of troponin T or I increase the number of patients referred to coronary angiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kasper Iversen, Dmsc | Contact | 28712753 | Kasper.karmark.iversen@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Bispebjerg | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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 | 0 |
| Number of MIs | The difference in the number of patients diagnosed with MI for each cardiac Troponin | 0 |
| PPV and NPV | The difference in positive predictive value and negative predictive value of each cardiac Troponin | 0 |
| Herlev-Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |