Myocardial Infarction Clinical Trial
Official title:
Sample Comparison With Siemens® Point-of-care Device for Cardiac Troponin I Assay by Using a Heparin Coated Transfer Device vs. Non-heparin Coated Transfer Device at the Emergency Department (Validation Study 2.0)
Verified date | June 2022 |
Source | VieCuri Medical Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 1, 2021 |
Est. primary completion date | December 19, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older. - Referred to cardiac ED with chest pain suspected of ACS; inclusion at arrival (T=0) or one hour after arrival (T=1). - Subacute STEMI or NSTEMI patients admitted at the CCU who have an indication for coronary angiography but do not need rescue/emergency PCI. - STEMI patients who already underwent rescue/emergency PCI; inclusion post PCI. Exclusion Criteria: - Out of hospital cardiac arrest. - Patients with sudden onset tachycardia and a frequency of 110 bpm or higher (supraventricular or ventricular). - Patients who are hemodynamically unstable or in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc. - Patients recently already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site. - Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Viecuri Medical Center | Venlo | Limburg |
Lead Sponsor | Collaborator |
---|---|
VieCuri Medical Centre | Siemens Corporation, Corporate Technology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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: Two capillary samples > one sample with a heparin coated transfer device (drawn from a finger of the right hand) and the other one with a non-heparin coated transfer device. (drawn from a finger of the left hand) One extra venous blood sample > for POC venous and POC plasma analysis. 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 | |
Secondary | 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 | |
Secondary | Linear regression and Pearson's correlation. | The relationship between POC sample types by linear regression and Pearson's correlation. | 30 days | |
Secondary | Overview baseline characteristics. | To create an overview of baseline characteristics of the population. | 30 days | |
Secondary | Major adverse cardiac event (MACE) | MACE is is defined as a composite of cardiac death and myocardial infarction. | 30 days | |
Secondary | Modified HEART score | To determine the modified HEART score retrospectively based upon POC capillary results in the population. | 30 days | |
Secondary | 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 |
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