Clinical trial NCT02107495: Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
Official title: Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congestive Heart Failure
Keywords: CHF
Lead sponsor: Samsung Electronics
Sponsor class: INDUSTRY
Collaborators: name: Nexus DX
First posted: 2014-04-08
Enrollment: 191
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).
timeFrame: baseline
measure: The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).
timeFrame: baseline
measure: 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.
timeFrame: baseline
Secondary outcomes:
measure: 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).
timeFrame: baseline
measure: 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).
timeFrame: baseline
measure: Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.
timeFrame: baseline
measure: 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.
timeFrame: 10 days
measure: 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.
timeFrame: 20 days
measure: Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: Minneapolis Medical Research Foundation
state: Minnesota
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
References: