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RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care | Clinical Trials | Clareo Health

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

Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)

NCT02191735•Response Biomedical Corp.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+14 more criteria

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

Locations (3)

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

Key Dates

Start Date

July 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

December 1, 2014

Last Updated

January 8, 2015

Enrollment

719

ACTUAL participants

Conditions

Acute Coronary SyndromeMyocardial InfarctionHeart FailureCongestive Heart Failure

Interventions

RAMP 200

DEVICE

RAMP Reader

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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