RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
C-POC
Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
1 other identifier
observational
719
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 8, 2015
January 1, 2015
4 months
July 10, 2014
January 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (4)
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.
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.
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.
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.
Interventions
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.
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 Criteria
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.
You may qualify if:
- 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)
- +3 more criteria
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
San Francisco General Hospital
San Francisco, California, 94110, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, 55404, United States
Biospecimen
EDTA plamsa specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert H Christenson, PhD
University of Maryland, Baltimore
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2014
First Posted
July 16, 2014
Study Start
July 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
January 8, 2015
Record last verified: 2015-01