Clinical trial NCT02191735: RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
Official title: Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Heart Failure
Congestive Heart Failure
Lead sponsor: Response Biomedical Corp.
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 600 total subjects, 18 years of age and older will be enrolled into this study at a minimum of 3 sites in the United States of America (USA).

Each site will screen for a minimum of approximately 200 clinical surplus whole blood samples derived from subjects presenting with symptoms and signs indicative of cardiovascular heart disease (i.e. acute myocardial infarction and/or heart failure). It is expected that the population will be divided approximately equally between males and females. Clinical site enrollment will be monitored throughout the trial to verify population distribution.

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 compared to the results for the same samples analyzed on the RAMP® Reader.


Eligibility criteria: 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

Primary outcomes:
measure: Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.
timeFrame: method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: Minneapolis Medical Research Foundation
state: Minnesota
Study officials:
affiliation: University of Maryland, Baltimore
name: Robert H Christenson, PhD
role: PRINCIPAL_INVESTIGATOR
References: