Demonstrating Minicare, a miniaturized biophotonics platform for fast and lab-equivalent Point-of-Care diagnostics

Completed

• Conditions: acute coronary syndrome; myocardial infarction; 10028593; 10003216

• Registration Number: NL-OMON40913
• Lead Sponsor: Philips

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 765

Inclusion Criteria

Patients who undergo work up for chest pain
Patients with elevated troponin concentration, e.g. after cardiac surgery

Exclusion Criteria

none,
only foor the 99th percentile reference study, the following criteria are used (stated in 4.2.11)
* Personal history of AMI or other cardiac diseases.
* Subject with hypertension
* Subject with known diabetes at the time of the enrollment.
* Subject with known renal insufficiency at the time of the enrollment
* Cardioactive drugs
* Recreational drug use

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In both work packages multiple outcome measures are defined. Please refer to<br /><br>the respective parts of the protocol.<br /><br>At the end of the study, the Minicare platform (hardware and software) and the<br /><br>troponin I test are in their final form and can undergo the CE marking process.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See study protocol</p><br>