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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Congestive Heart Failure Heart Diseases Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco General Hospital, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Study Arms A - Troponin I (ACS/MI)

Males or Females, 18 years of age or older, of any race
Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms B - Myoglobin (ACS/MI)

Males or Females, 18 years of age or older, of any race
Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.
Willing to voluntarily agree to sign a consent form (if applicable)

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

Males or Females, 18 years of age or older, of any race
Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.
Willing to voluntarily agree to sign a consent form (if applicable)

Study Arm D - NT-proBNP (HF)

Males or Females, 18 years of age or older, of any race
Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines
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)

Healthy Subjects
Pregnant or lactating
Subjects not having a cardiac marker test ordered
Blood sample collected >24 hours prior to screening
Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
Non-compliance to the protocol or the inclusion criteria

Study Arm D - NT-proBNP (HF)

Healthy Subjects
Pregnant or lactating
Subjects not having a cardiac marker test ordered
Blood sample collected >24 hours prior to screening
Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
Non-compliance to the protocol or the inclusion criteria

Treatment and study plan

RAMP 200

Device

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

Device

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.

Primary outcomes

Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running 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.
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.

Sponsors and collaborators

Lead sponsor

Response Biomedical Corp.

Industry

Registry information

Official study title

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

Acronym: C-POC

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jul 16, 2014
Registry last updated: Jan 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed