C-POC: RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care

• Sponsor: Response Biomedical Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02191735
• Collaborator: (none)
• Enrollment: 719
• Locations: 3
• Duration (Months): 5
• Patients Per Site: 239.7
• Patients Per Site Per Month: 47.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Myocardial Infarction; Heart Failure; Congestive Heart Failure	Device: RAMP 200; Device: RAMP Reader

Study Design

• Study Type: Observational
• Actual Enrollment: 719 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Troponin I Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.	Device: RAMP 200; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.; Device: RAMP Reader; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.
Myoglobin Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP Myoglobin test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.	Device: RAMP 200; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.; Device: RAMP Reader; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.
CK-MB Subjects who have undergone a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) and who have a RAMP CK-MB test result that is within the test reportable range. Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.	Device: RAMP 200; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.; Device: RAMP Reader; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.
NT-proBNP Subjects who have undergone a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF). Waste sample blood will then be tested on the RAMP 200 and the RAMP Reader for comparison.	Device: RAMP 200; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.; Device: RAMP Reader; The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.

Outcome Measures

Primary Outcome Measures

1. Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests. [method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.]

   The primary objective is to achieve substantial equivalence of the RAMP® cardiac tests on the RAMP® Reader and the RAMP® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications: precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials; precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and, performance via method comparison across the reportable ranges of the RAMP® cardiac tests.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94110
2	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
3	Minneapolis Medical Research Foundation	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Response Biomedical Corp.

Investigators

• Principal Investigator: Robert H Christenson, PhD, University of Maryland Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Response Biomedical Corp.
• ClinicalTrials.gov Identifier: NCT02191735
• Other Study ID Numbers: CSP024
• First Posted: Jul 16, 2014
• Last Update Posted: Jan 8, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Heart Failure; Myocardial Infarction; Acute Coronary Syndrome; Infarction

Study Results

No Results Posted as of Jan 8, 2015