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This clinical investigation is designed to demonstrate the performance characteristics of the RAMPĀ® cardiac tests analyzed on the RAMPĀ® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMPĀ® Reader.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAMP 200 | Device | The RAMPĀ® 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 RAMPĀ® 200 is Response Biomedical's second generation reader. The RAMPĀ® 200 is designed to process more tests with a smaller footprint. |
| Measure | Description | Time Frame |
|---|---|---|
| Substantial Equivalence of the RAMPĀ® Reader and the RAMPĀ® 200 when running the RAMPĀ® Cardiac tests. | The primary objective is to achieve substantial equivalence of the RAMPĀ® cardiac tests on the RAMPĀ® Reader and the RAMPĀ® 200 in a point-of-care (POC) setting by evaluating the following analytical performance specifications:
| method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months. |
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Inclusion Criteria:
Study Arms A - Troponin I (ACS/MI)
Study Arms B - Myoglobin (ACS/MI)
Study Arms C - CK-MB (ACS/MI)
Study Arm D - NT-proBNP (HF)
Exclusion Criteria:
Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)
Study Arm D - NT-proBNP (HF)
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Christenson, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States | ||
| University of Maryland Medical Center |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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EDTA plamsa specimens
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| RAMP Reader | Device | The RAMPĀ® 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 RAMPĀ® 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. |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| Minneapolis Medical Research Foundation | Minneapolis | Minnesota | 55404 | United States |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |