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| ID | Type | Description | Link |
|---|---|---|---|
| METCZ20200008 | Other Identifier | Medical ethical committee | |
| NL72445.096.20 | Other Identifier | ToetsingOnline ID/CCMO ID |
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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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This study is a prospective, diagnostic, cohort study within the standard care of acute coronary syndrome (ACS) patients. It compares the analytical performance of Siemens® point-of-care high sensitive troponin I testing in venous, plasma and capillary sample types. The investigators hypothesize that there is a good correlation between the Siemens® POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from ~10% to ≤ 5% when using heparinized transfer device for the capillary sample.
In September 2019, the validation study 1.0 started, in which the cTnI result of the Siemens POC device on three sample types are compared. Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock, and calculating the Pearson correlation coefficient.
The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 1.00-1.03 with an R of >0.99, so the results between these sample types can be used interchangeably. For the capillary sample vs the Li-hep sample (both blood and plasma) the slope is 8-12% higher. With a 8-12% higher response, the capillary test results may not be interchangeably used with the other 2 sample types.
It is remarkable that capillary samples give a higher response, since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid. The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration. By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device, this hypothesis will be tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest pain patients | Patients are eligible for participation if they are admitted to:
Troponin analysis will be performed according to standard protocol. From every included patient two capillary blood samples and an extra venous blood sample will be drawn during regularly ordered blood work to evaluate HS cTnI levels obtained with the POC instrument. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siemens® Point-of-care high sensitive troponin I analyzer | Device | Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device. |
| Measure | Description | Time Frame |
|---|---|---|
| Sample comparison | The primary objective is to compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the coefficient of variation. This comparison will comprise Siemens® POC capillary vs. Siemens® POC venipuncture and vs. Siemens® POC plasma (Sample comparison). The primary objective will be achieved by taking:
Trained clinical staff will collect the different samples. All samples will be collected once, at one time point with a maximum of 10 minutes in between. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bland-Altman method | To compare the analytical performance of Siemens® point-of-care high sensitive troponin I testing in different sample types by using the Bland-Altman method. | 30 days |
| Linear regression and Pearson's correlation. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients presented at our cardiology ED or coronary care unit (CCU) are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, ECG and regular troponin results from the central laboratory.
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| Name | Affiliation | Role |
|---|---|---|
| Braim Rahel, Dr. | VieCuri Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viecuri Medical Center | Venlo | Limburg | 5912 BL | Netherlands |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Capillary blood, venous blood and blood plasma
The relationship between POC sample types by linear regression and Pearson's correlation.
| 30 days |
| Overview baseline characteristics. | To create an overview of baseline characteristics of the population. | 30 days |
| Major adverse cardiac event (MACE) | MACE is is defined as a composite of cardiac death and myocardial infarction. | 30 days |
| Modified HEART score | To determine the modified HEART score retrospectively based upon POC capillary results in the population. | 30 days |
| Modified HEART score comparison | To compare the retrospectively determined modified HEART score based upon POC capillary heparin coated transfer device with the retrospectively determined modified HEART score based upon POC capillary non-heparin coated transfer device. | 30 days |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |