Point of Care Precision and Sample Comparison Study of Minicare BNP at Innsbruck Hospital - MI-BNP-CE04-AN2016

October 17, 2017 updated by: Philips Handheld Diagnostics

Part 1 (POC Precision):

Objective :

Demonstrate that the Minicare BNP (im)precision in hands of the user is within the expected range of the Minicare BNP (im)precision. Part 2 (sample comparison)

Primary objective :

Compare Minicare BNP values from capillary whole blood from finger stick with EDTA whole blood from venous puncture.

Secondary objective :

Compare Minicare BNP values from EDTA whole blood and plasma with Li- Heparin whole blood and plasma from venous puncture.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design Part 1 (POC precision) Two levels of BNP control samples (Thermofisher) will be tested during 5 days, with 5 replicates per day by three different users to assess precision of the Minicare BNP. The two different levels need to be tested on the same analyzer by the same user. For this study, six analyzers are made available, meaning that each user will test 2 analyzers. In parallel this testing will be done at Philips to establish the expected POC (im)precision. The two (im)precision values will be compared to each other. The precision study will also be used as a proficiency study that is normally requested prior to starting enrolment. Study Design Part 2 (sample comparison)

Part 2 (Sample comparison):

This study will be a prospective European single site study with at least 100 patient samples, taken from patients presenting at the cardiology ward and coronary care unit with suspected/ diagnosed heart failure (HF) or other cardiac diseases and thus suspected elevated BNP values. The blood sample will be collected near the patient by a trained healthcare professional of the study site.

When testing capillary whole blood, the blood will be collected by a finger stick according to the local SOP's of the study site. Directly (within 1 minute) after finger stick, the blood will be transferred with capillary transfer devices, one without ant-coagulant and one containing EDTA as anti-coagulant, to the BNP cartridge that is positioned in the Minicare I-20 analyzer. Testing will be done near the bedside of the patient. Two venous whole blood tubes will be collected; one containing Li-Heparin and the other containing EDTA as anti-coagulant. The venous whole blood will be collected in the specific tubes by a venous puncture according to the local SOP's of the study site. The EDTA venous whole blood will be transferred to the Minicare BNP by using a pipet and a transfer device. The Li-Heparin and EDTA venous whole blood sample should be tested within 2 hours (keep at room temperature) after the blood is taken (preferably as soon as possible after blood taking). Li-Heparin and EDTA venous whole blood can be tested at the ward by a trained healthcare professional or in the lab by a trained lab technician. The Li-Heparin and EDTA whole blood sample will be transferred to the lab and centrifuged and tested within 2 hours after the blood is taken. The Li-Heparin and EDTA plasma should be tested within 2 hours (keep at room temperature) after the blood is taken (preferably as soon as possible after blood taking). Li- Heparin and EDTA plasma samples might be tested in the lab, dependent on local routine.

All patient samples will be tested in singleton. The time that the blood is taken and tested will be recorded for each sample. Study will continue until at least 100 patient samples covering the predefined concentration range have valid measurements. Due to experience from previous sample comparison studies (Lab2Go) the site expects the necessity to test up to 200 patients to find 100 patients within the required BNP ranges. The Minicare BNP test results will not be used as part of the patient diagnosis but only for sample comparison purposes. Testing for both Part 1 and Part 2 will be done according to the Clinical Brochure for Minicare BNP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medical University of Innsbruck
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient samples from eligible patients with BNP requests, available at the test site

Description

Inclusion criteria:

  • 18 years or older
  • patients with suspected/ diagnosed heart failure (HF)
  • signed informed consent form

Exclusion criteria:

  • Patients younger than 18 years
  • Patients requiring emergency treatment, those with cognitive impairment or inability to understand study information, and those unwilling or unable to provide written consent
  • Patients already participated in this study
  • Pregnant or breastfeeding women
  • Patients with known Hepatitis B or C or HIV infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
POC precision objective
Time Frame: June 2017
Demonstrate that the Minicare BNP (im)precision in hands of the user is within the expected range of the Minicare BNP (im)precision.
June 2017
Sample comparison objective
Time Frame: June 2017
Compare Minicare BNP values from capillary whole blood from finger stick with EDTA whole blood from venous puncture.
June 2017

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sample comparison secondary objective
Time Frame: June 2017
Compare Minicare BNP values from EDTA whole blood and plasma with Li- Heparin whole blood and plasma from venous puncture.
June 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philips Handheld Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johannes Mair, Senior Staff member

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HHDx-08698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data outcome of study may be included in publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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