RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care

Heart Failure Clinical Trial

— C-POC  

Official title:

Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191735
• Other study ID #: CSP024
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: January 7, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Response Biomedical Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Study Arms A - Troponin I (ACS/MI)

1. Males or Females, 18 years of age or older, of any race

2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines

3. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms B - Myoglobin (ACS/MI)

1. Males or Females, 18 years of age or older, of any race

2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines

3. Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.

4. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms C - CK-MB (ACS/MI)

1. Males or Females, 18 years of age or older, of any race

2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines

3. CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.

4. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arm D - NT-proBNP (HF)

1. Males or Females, 18 years of age or older, of any race

2. Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines

3. Willing to voluntarily agree to sign a consent form (if applicable)

Exclusion Criteria:

Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)

1. Healthy Subjects

2. Pregnant or lactating

3. Subjects not having a cardiac marker test ordered

4. Blood sample collected >24 hours prior to screening

5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing

6. Non-compliance to the protocol or the inclusion criteria

Study Arm D - NT-proBNP (HF)

1. Healthy Subjects

2. Pregnant or lactating

3. Subjects not having a cardiac marker test ordered

4. Blood sample collected >24 hours prior to screening

5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing

6. Non-compliance to the protocol or the inclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Congestive Heart Failure
• Heart Failure
• Myocardial Infarction

Intervention

Device:
• RAMP 200
The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.
• RAMP Reader
The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Minneapolis Medical Research Foundation	Minneapolis	Minnesota
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Response Biomedical Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.	The primary objective is to achieve substantial equivalence of the RAMP® cardiac tests on the RAMP® Reader and the RAMP® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications: precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials; precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and,; performance via method comparison across the reportable ranges of the RAMP® cardiac tests.	method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.	No