EU Performance Evaluation Study for the Philips Minicare cTn-I Test
Research type
Research Study
Full title
European Performance Evaluation Study for the Philips Minicare cTn-I Test
IRAS ID
173407
Contact name
Diederick Keizer
Contact email
Sponsor organisation
Philips Electronics Nederland B.V., Handheld Diagnostics
ISRCTN Number
ISRCTN77371338
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
The Minicare cTn-I system is intended to be used as an aid in the diagnosis of myocardial infarction (heart attack).
This European Performance Evaluation Study of Minicare cTn-I system is a performance evaluation designed to evaluate whether the investigational device, the Minicare cTn-I is suitable for use to assist in the diagnosis of heart attack for patients presenting at the emergency department (ED) with suspicion of a heart condition. The effectiveness of the Minicare cTn-I will be compared with the performance of the standard procedure used at the participating site.
Blood samples will be collected from patients, presenting at the Emergency Department, displaying symptoms suggestive of heart condition.
The study is expected to last up to 7 months after first patient enrollment with approximately 550 patients being recruited across 4 EU countries. Recruitment will be stopped as soon as 50 patients with a confirmed heart attack have been enrolled. These patients must also have had a blood sample taken between 6-24 hrs after arrival at the Emergency Department.
If 0 or 2-4 hours samples definitively confirms a heart attack then 6-24 hour samples will not be taken.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
15/WM/0088
Date of REC Opinion
14 Apr 2015
REC opinion
Further Information Favourable Opinion