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

N/ACompletedNCT02191735

Response Biomedical Corp.719 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

719

Conditions

Acute Coronary Syndrome Myocardial Infarction Heart Failure Congestive Heart Failure

Interventions

RAMP 200DEVICE

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 ReaderDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

San Francisco General Hospital

San Francisco, California, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Minneapolis Medical Research Foundation

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.

Data from ClinicalTrials.gov

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