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RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care (C-POC)

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ClinicalTrials.gov Identifier: NCT02191735
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Myocardial Infarction Heart Failure Congestive Heart Failure Device: RAMP 200 Device: RAMP Reader

Study Design

Study Type : Observational
Actual Enrollment : 719 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
Study Start Date : July 2014
Primary Completion Date : November 2014
Study Completion Date : December 2014
Groups and Cohorts

Group/Cohort Intervention/treatment
Troponin I
Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
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.
Device: 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.
Myoglobin
Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP Myoglobin test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
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.
Device: 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.
CK-MB
Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP CK-MB test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
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.
Device: 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.
NT-proBNP
Subjects who have undergone a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.
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.
Device: 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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
EDTA plamsa specimens

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 600 total subjects, 18 years of age and older will be enrolled into this study at a minimum of 3 sites in the United States of America (USA).

Each site will screen for a minimum of approximately 200 clinical surplus whole blood samples derived from subjects presenting with symptoms and signs indicative of cardiovascular heart disease (i.e. acute myocardial infarction and/or heart failure). It is expected that the population will be divided approximately equally between males and females. Clinical site enrollment will be monitored throughout the trial to verify population distribution.

Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191735


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Minnesota
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Response Biomedical Corp.
Investigators
Principal Investigator: Robert H Christenson, PhD University of Maryland
More Information

Responsible Party: Response Biomedical Corp.
ClinicalTrials.gov Identifier: NCT02191735     History of Changes
Other Study ID Numbers: CSP024
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases