Sample and method comparison with Minicare point-of-care device for cardiac troponin I assay at the emergency department.

Completed

Conditions: acute coronary syndrome
heart attack
10028593

Registration Number: NL-OMON48350

Lead Sponsor: Viecuri Medisch Centrum voor Noord-Limburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

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

* 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Minicare POC (different sample types) vs conventional HS cTnI CL test (Method<br /><br>comparison)<br /><br>* Minicare capillary vs. Minicare venipuncture and vs. Minicare plasma (Sample<br /><br>comparison)<br /><br><br /><br>The analyses linked to the primary objectives are:<br /><br>* The agreement between POC (three sample types) and CL testing by using the<br /><br>Bland-Altman method.<br /><br>* The relationship between POC (three sample types) and CL by linear regression<br /><br>and Pearsons correlation.<br /><br> The agreement between different POC sample types by using the Bland-Altman<br /><br>method.<br /><br>* The relationship between POC sample types by linear regression and Pearson*s<br /><br>correlation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* To create an overview of baseline characteristics of the population.<br /><br>* The mortality and major adverse cardiovascular events (MACE) of the<br /><br>population at 30 days. MACE is defined as a composite of cardiac death and<br /><br>myocardial infarction.<br /><br>* To compare final patients diagnosis (ACS vs. no ACS) and treatment based on<br /><br>POC venous troponin testing versus CL plasma troponin I testing versus HS cTnT<br /><br>plasma testing (regular patient care).<br /><br>* To create an overview of the sensitivity, specificity, negative predictive<br /><br>value (NPV) and positive predictive value (PPV) of POC and standard laboratory<br /><br>troponin I testing.<br /><br>* To determine amount of false positive and false negative results for the POC<br /><br>and if there is a significant difference compared to CL testing. </p><br>