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

Use our guide to learn which trials are right for you!

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.


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
1001 Potrero Ave
San Francisco, California 94110
(415) 206-8000
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials