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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40913
Enrollment
765
Registered
2014-10-02
Start date
2015-09-09
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome myocardial infarction

Interventions

None listed

Sponsors

Philips
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
See study protocol

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)