RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care

Completed

Conditions studied: Acute Coronary Syndrome, Myocardial Infarction, Heart Failure, Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT02191735

Run by

Response Biomedical Corp.

People needed

719

Starts

2014-07-01

Expected to finish

2014-12-01

Last updated by the study team

2015-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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)

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
• 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

Where it is running

• San Francisco General Hospital — San Francisco, California, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Minneapolis Medical Research Foundation — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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