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

Completed

• Conditions: Myocardial Infarction; Acute Coronary Syndrome; Heart Failure; Congestive Heart Failure
• Interventions: Device: RAMP 200; Device: RAMP Reader

• Registration Number: NCT02191735
• Lead Sponsor: Response Biomedical Corp.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 719

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Troponin I	RAMP Reader	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.
CK-MB	RAMP Reader	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.
Troponin I	RAMP 200	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.
Myoglobin	RAMP 200	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.
CK-MB	RAMP 200	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.
NT-proBNP	RAMP 200	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.
Myoglobin	RAMP Reader	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.
NT-proBNP	RAMP Reader	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Minneapolis Medical Research Foundation; 🇺🇸 Minneapolis, Minnesota, United States

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States