acute coronary syndrome heart attack
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Patients 18 years or older with chest pain suspected of ACS. * STEMI patient who already underwent rescue PCI; inclusion post PCI.
Exclusion criteria
Exclusion criteria: * Out of hospital cardiac arrest. * Patients with sudden onset tachycardia and a frequence 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Minicare POC (different sample types) vs conventional HS cTnI CL test (Method comparison) * Minicare capillary vs. Minicare venipuncture and vs. Minicare plasma (Sample comparison) The analyses linked to the primary objectives are: * The agreement between POC (three sample types) and CL testing by using the Bland-Altman method. * The relationship between POC (three sample types) and CL by linear regression and Pearson*s correlation. * The agreement between different POC sample types by using the Bland-Altman method. * The relationship between POC sample types by linear regression and Pearson*s correlation. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To create an overview of baseline characteristics of the population. * The mortality and major adverse cardiovascular events (MACE) of the population at 30 days. MACE is defined as a composite of cardiac death and myocardial infarction. * To compare final patients diagnosis (ACS vs. no ACS) and treatment based on POC venous troponin testing versus CL plasma troponin I testing versus HS cTnT plasma testing (regular patient care). * To create an overview of the sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of POC and standard laboratory troponin I testing. * To determine amount of false positive and false negative results for the POC and if there is a significant difference compared to CL testing. | — |
Countries
Netherlands