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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Response Biomedical Corp.
Sponsor:
Information provided by (Responsible Party):
Response Biomedical Corp.
ClinicalTrials.gov Identifier:
NCT02191735
First received: July 10, 2014
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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 Intervention
Acute Coronary Syndrome
Myocardial Infarction
Heart Failure
Congestive Heart Failure
Device: RAMP 200
Device: RAMP Reader

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Response Biomedical Corp.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 600
Study Start Date: July 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02191735

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Erin Shea    415-640-2541      
Principal Investigator: Alan Wu, PhD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Heather Rebuck    410-706-7734      
Principal Investigator: Robert H Christenson, PhD         
United States, Minnesota
Minneapolis Medical Research Foundation Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: MaryAnn Murakami    612-873-6891      
Contact: Betty Kilburn    612.873.6890      
Principal Investigator: Fed Apple, PhD         
Sponsors and Collaborators
Response Biomedical Corp.
Investigators
Principal Investigator: Robert H Christenson, PhD University of Maryland
  More Information

No publications provided

Responsible Party: Response Biomedical Corp.
ClinicalTrials.gov Identifier: NCT02191735     History of Changes
Other Study ID Numbers: CSP024
Study First Received: July 10, 2014
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014