RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
Status: | Completed |
---|---|
Conditions: | Cardiology, Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2015 |
Start Date: | July 2014 |
End Date: | November 2014 |
Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
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.
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.
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
We found this trial at
3
sites
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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