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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02107495
• Other study ID #: A20-01
• Status: Terminated
• Phase: N/A
• First received: April 3, 2014
• Last updated: April 18, 2016
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Samsung Electronics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 191
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Samsung LABGEO IVD-A20 CHF Test

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Minneapolis Medical Research Foundation	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Electronics	Nexus-Dx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).		baseline	No
Primary	The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).		baseline	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.	This analysis will assess the ability of the Samsung LABGEO IVD-A20 CHF Test to discriminate between confirmed CHF subjects and non-CHF subjects.	baseline	No
Secondary	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.	The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days.	10 days	No
Secondary	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.	The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days.	20 days	No
Secondary	Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition.	The natural logarithm of the Samsung LABGEO IVD-A20 CHF Test measurement will be modeled as a linear function of time (in hours) after baseline testing.A separate linear function will be fitted to data collected from each study specimen and the intercepts and slops from individual specimens will be modeled as random effects.	48 hours	No