Status:
COMPLETED
RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
Lead Sponsor:
Response Biomedical Corp.
Conditions:
Acute Coronary Syndrome
Myocardial Infarction
Eligibility:
All Genders
18+ years
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
719 Patients enrolled
Trial Details
Trial ID
NCT02191735
Start Date
July 1 2014
End Date
December 1 2014
Last Update
January 8 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco General Hospital
San Francisco, California, United States, 94110
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States, 55404