Determining Normal Values of BNP Levels for the Minicare BNP IVD Assay.

Healthy Clinical Trial

Official title:

Minicare BNP Normal Value Study - MI-BNP-CE02-NV2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102944
• Other study ID #: HHDx-07998
• Status: Completed
• Phase: N/A
• First received: March 31, 2017
• Last updated: October 17, 2017
• Start date: March 21, 2017
• Est. completion date: March 24, 2017

Study information

• Verified date: March 2017
• Source: Philips Handheld Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Main objective is to determine normal values for Brain Natriuretic Peptide (BNP) levels for the Minicare BNP using K2-EDTA (ethylenediaminetetraacetic acid ) venous whole blood and K2-EDTA plasma samples from healthy subjects.

K2-EDTA whole blood and K2-EDTA plasma samples from approximately 150 normal healthy volunteer, preferably 50% men and 50% women, will be analysed using the Minicare BNP system. This will be a single-center study. The study will consist of a 1-day visit for each study subject on which screening based on a questionnaire, blood draw and discharge will occur. For each eligible subject, K2-EDTA whole blood will be collected and both K2-EDTA whole blood and K2-EDTA plasma will be analyzed using the Minicare BNP. Blood donors, presenting voluntarily at one of the Sanquin posts in, the Netherlands (e.g Eindhoven) will be checked on health status and selected based on 2 questionnaires. The collected K2-EDTA whole blood tubes from eligible subjects will be transferred from the Sanquin posts to Philips Eindhoven for Minicare BNP testing. From one subject, both K2-EDTA whole blood and K2-EDTA plasma will be measured in singleton. K2-EDTA whole blood and plasma will be measured within 6 hours after blood collection. The data obtained will be used for determination of normal values of BNP in a healthy population. Leftover plasma samples (without cells/ RNA/DNA) will be aliquoted and stored at Philips for potential future analysis/ projects). Testing will be done according to a DRAFT Instructions for use (IFU) of the Minicare BNP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 24, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years old

• Willing and able to sign the informed consent form (ICF)

Exclusion Criteria:

• Subjects suffering from cardiac and/or vascular disease, renal dysfunction, hypertension, cancer, Chronic Obstructive Pulmonary Disease (COPD), instable diabetes, pregnancy and extreme overweight are not allowed to donate blood.

• Subjects with a history of cardiac and/or vascular disease, renal dysfunction, cancer, COPD or instable diabetes are not allowed to donate blood.

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• Minicare BNP
no real intervention since only leftover materials are used from volunteers and samples are not tested on Minicare BNP IVD device near any volunteer.

Locations

Country	Name	City	State
Netherlands	Philips EB Handheld Diagnostics	Eindhoven

Sponsors (1)

Lead Sponsor	Collaborator
Philips Handheld Diagnostics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal values for BNP for the Minicare BNP	To determine normal values for BNP levels for the Minicare BNP using K2- EDTA venous whole blood and K2-EDTA plasma samples from healthy subjects.	4 weeks