Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting

NCT02107495 | Terminated

• 1 other identifier: A20-01
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 3

Brief Summary

To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.

Conditions

Congestive Heart Failure

Keywords

CHF

Outcome Measures

Primary Outcomes (3)

• The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).

  baseline

• The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).

  baseline

• Using a Passing-Bablok regression analysis, estimates of intercept and slope will be computed. Estimates of bias and corresponding 95% confidence interval for true bias at clinical decision threshold of 125mg/mL and 450 pg/mL will also be computed.

  Method comparison will be assessed using a Passing-Bablok regression analysis to determine the relationship between the Samsung LABGEO IVD-A20 CHF Test measurement in plasma and the corresponding measurement in plasma obtained from the comparator assay.

  baseline

Secondary Outcomes (6)

• The proportion of subjects with a positive LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (positive predictive value).

  baseline

• The proportion of subjects with a negative LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (negative predictive value).

  baseline

• Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.

  baseline

• Variance components analysis will be conducted on data collected from each whole blood specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.

  10 days

• Variance components analysis will be conducted on data collected from each plasma specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.

  20 days

Study Arms (3)

CHF-confirmed subjects

Subjects 21 years of age or greater with clinically confirmed heart failure or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.

Device: Samsung LABGEO IVD-A20 CHF Test

Subjects with potentially co-morbidities

non-CHF subjects 21 years or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD).

Device: Samsung LABGEO IVD-A20 CHF Test

Apparently healthy subjects

Apparently healthy subjects (meeting inclusion criteria) greater than 45 years of age, with no prior history of myocardial infarction (MI), acute coronary syndrome (ACS) congestive heart failure (CHF) or any other cardiac-related disease.

Device: Samsung LABGEO IVD-A20 CHF Test

Interventions

Samsung LABGEO IVD-A20 CHF Test DEVICE

Also known as: LABGEO IVD-A20 CHF Test, A20 CHF Test,

Apparently healthy subjects; CHF-confirmed subjects; Subjects with potentially co-morbidities

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects to be recruited for this study will be presenting to one of five point of care sites located in the USA. The sites will be emergency room or POL sites, and will include primary care facilities representative of those typically serving the intended use population for the test.

You may qualify if:

• CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.
• Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)
• Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.

You may not qualify if:

• Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;
• Subjects with acute decompensated heart failure currently on nesiritide therapy;
• Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and
• Subjects unable to or refusing to provide written informed consent.

Sponsors & Collaborators

• Samsung Electronics: lead
• Nexus DX: collaborator

Study Sites (3)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Minneapolis Medical Research Foundation

Minneapolis, Minnesota, 55404, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retaining plasma specimens

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2015-02

Locations

US (3)