Clinical trial NCT04153006: Comparison of Fingerstick Versus Venous Sample for Troponin I.
Official title: Sample and Method Comparison With Minicare® Point-of-care Device for Cardiac Troponin I Assay at the Emergency Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Myocardial Infarction
Myocardial Ischemia
Heart Attack
Keywords: Troponin
Point-of-care
Minicare
Lead sponsor: VieCuri Medical Centre
Sponsor class: OTHER
Collaborators: name: Siemens Healthcare Diagnostics Inc
name: Minicare® B.V.
First posted: 2019-11-06
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presented at our cardiology ED are eligible for inclusion if they are 18 years or older and suspected of having an ACS based on history, examination, and ECG.

Brief summary: This study is a prospective, observational, cohort study aiming to compare point-of-care high-sensitive troponin I testing from different sample types with central laboratory (CL) HS cTnI plasma samples.

A registry of all included patients and their troponin results (POC, CL and HS cTnT) will be made to compare these testing methods.

Detailed description: Point-of-care (POC) troponin testing, defined as laboratory testing near a patient location with rapid availability of results, has attracted much interest in the emergency department setting (ED) and seems feasible. These devices might enable earlier decisions, reduce stay at the ED and improve patient flow. While an elevated troponin in patients with suspected acute coronary syndrome (ACS) confirms diagnosis and initiates adequate treatment, ruling out ACS aids in proper patient dismissal. A next step could be ruling out myocardial infarction by the general practitioner (GP) or fast responder using an on-site POC troponin test. However, drawing venous blood might not be easily available to every GP, especially not during peak hours. The Minicare cTnI is a bedside system which requires capillary blood, venous whole blood or plasma. The results of the troponin will be given within 10 minutes. It is a very sensitive troponin test, the most clinically sensitive available POC for c-Troponin. Currently Minicare prepares for a high sensitive troponin analysis targeting a reliable result within an hour after onset of chest pain. The objective of this study is to determine if high sensitive troponin testing by Minicare (POC HS cTnI) has the same analytical performance as standard high sensitivity troponin I testing in our central hospital laboratory ( CL HS cTnI ARCHITECT immunoassay analyzer, Abbott).

Eligibility criteria: Inclusion criteria:

• Patients 18 years or older with chest pain suspected of ACS.

Exclusion criteria:

* ST elevation myocardial infarction and 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.

Primary outcomes:
measure: Method and sample comparison
timeFrame: 30 days
Secondary outcomes:
measure: Major adverse cardiac event (MACE)
timeFrame: 30 days
measure: Final patients diagnoses.
timeFrame: 30 days
measure: Overview baseline characteristics.
timeFrame: 30 days
measure: Linear regression and Pearson's correlation.
timeFrame: 30 days
measure: Fals-positive and fals-negatives.
timeFrame: 30 days
measure: Safety analysis of POC troponin.
timeFrame: 30 days
Other outcomes:
Locations:
city: Venlo
country: Netherlands
facility: Viecuri MC
state: Limburg
Study officials:
affiliation: Viecuri MC
name: Braim Rahel, Dr.
role: PRINCIPAL_INVESTIGATOR
References: