European performance evaluation study for the Philips Minicare cTn-I system

• Register: ISRCTN
• Last refreshed on: 20 March 2023
• Main ID: ISRCTN77371338
• Date of registration: 13/02/2015
• Prospective Registration: Yes
• Primary sponsor: Philips Electronics Nederland B.V., Handheld Diagnostics
• Public title: European performance evaluation study for the Philips Minicare cTn-I system
• Scientific title: European performance evaluation study for the Philips Minicare cTn-I system: an observational study
• Date of first enrolment: 01/04/2015
• Target sample size: 550
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN77371338
• Study type: Observational
• Study design: Multi-center prospective non-randomized open surveillance study (Diagnostic)
• Phase: Not Specified

Countries of recruitment

Austria, France, Germany, Netherlands

Contacts

• Name: Diederick Keizer

Key inclusion & exclusion criteria

Inclusion criteria:
1. = 18 years old
2. Patients presenting with symptoms suggestive of ACS, at ED or CCU
3. Patients presenting for the first time after onset of symptoms
4. Onset of last episode of symptoms suggestive of AMI <12 hrs prior to presentation to ER
5. Signed Informed Consent Form

Exclusion criteria:
1. Patients already admitted for the same set of symptoms at a previous healthcare institution before being transferred to the participating clinical site
2. Patients not willing or not able to provide informed consent due to their medical condition as judged by the physician


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Measuring cardiac cTn-I at the patient's bedside as an aid in the diagnosis of myocardial infarction (MI)
Circulatory System

Intervention(s)

Patients will have blood samples drawn in the ER (or CCU) at three different time points: when possible t=0 at presentation at ED of the hospital (defined as baseline sample), followed at 2 – 4 hours, and at 6 – 24 hours after first blood sample if the patient is still in the hospital at these time points. About 550 patients suspected of ACS will be enrolled. Enrollment will be stopped after positive adjudication of 50 patients with confirmed AMI, including the 6-24 blood sample.

Primary Outcome(s)

Current primary outcome measures as of 21/09/2017:
Sensitivity and specificity of Minicare cTnI in Li-Hep whole blood and Li-Hep plasma, calculated using the 99th percentile URL value of 43 ng/L, measured at 0h, 2-4h and 6-24h after presentation

Previous primary outcome measures:
From each enrolled patient, Li-heparin plasma and Li-heparin whole blood samples will be analyzed using the Minicare cTn-I System. In parallel, Li-heparin plasma sample will be tested using the hospital standard cTn assay (Elecsys Troponin T high sensitive Roche). Leftover of Li-heparin plasma will be stored for further analysis (aliquots at -80°C).

The final diagnosis of AMI will be based on adjudication by an external board of cardiologists. Only patients with at least one cTn result above the 99th perc. URL using the hospital standard cTn method will be adjudicated. All other patients will be assumed non-MI.

Secondary Outcome(s)

Current secondary outcome measures as of 21/09/2017:
The positive and negative predictive value of Minicare cTnI in Li-Hep whole blood and Li-Hep plasma, calculated using the 99th percentile URL value of 43 ng/L, measured at 0h, 2-4h and 6-24h after presentation

Previous secondary outcome measures:
1. To estimate the positive and negative predictive value of the Minicare cTn-I System
2. To evaluate the overall agreement between the Minicare cTn-I Test System and the hospital standard cTn assay
3. To evaluate agreement between Li-heparin plasma and Li-heparin whole blood

Primary and secondary outcomes are related to the same data collection set and will be evaluated after close of the study and during data analysis.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Philips

Ethics review

Status:
Approval date:
Contact:

1. Germany: Ethik-Kommission der FAU (Friedrich-Alexander Universitat Erlangen Nurnberg – Medizinische fakultat), 31/03/2015, ref: 381_14 Mz 2. France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de Ia santé (CCTIRS), 15/04/2015, ref: CCTIRS N" 15.329 3. Netherlands: Medisch-Etische Toetsingscommissie van het Catharina Ziekenhuis te Eindhoven, 27/03/2015, ref: AN204-0280 341/4.18 347/5

Results

• Results available: Yes
• Date Completed: 31/12/2015