Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02191735
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EDTA plamsa specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 719}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': '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:\n\n* precision on the RAMP® 200, when used at maximum complexity, utilizing frozen control materials;\n* precision on the RAMP® 200, when used at maximum complexity, utilizing whole blood specimens; and,\n* performance via method comparison across the reportable ranges of the RAMP® cardiac tests.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Myocardial Infarction', 'Heart Failure', 'Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).\n\nEach 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy Arms A - Troponin I (ACS/MI)\n\n1. Males or Females, 18 years of age or older, of any race\n2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines\n3. Willing to voluntarily agree to sign a consent form (if applicable)\n\nStudy Arms B - Myoglobin (ACS/MI)\n\n1. Males or Females, 18 years of age or older, of any race\n2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines\n3. Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.\n4. Willing to voluntarily agree to sign a consent form (if applicable)\n\nStudy Arms C - CK-MB (ACS/MI)\n\n1. Males or Females, 18 years of age or older, of any race\n2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines\n3. CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.\n4. Willing to voluntarily agree to sign a consent form (if applicable)\n\nStudy Arm D - NT-proBNP (HF)\n\n1. Males or Females, 18 years of age or older, of any race\n2. Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines\n3. Willing to voluntarily agree to sign a consent form (if applicable)\n\nExclusion Criteria:\n\nStudy Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)\n\n1. Healthy Subjects\n2. Pregnant or lactating\n3. Subjects not having a cardiac marker test ordered\n4. Blood sample collected \\>24 hours prior to screening\n5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing\n6. Non-compliance to the protocol or the inclusion criteria\n\nStudy Arm D - NT-proBNP (HF)\n\n1. Healthy Subjects\n2. Pregnant or lactating\n3. Subjects not having a cardiac marker test ordered\n4. Blood sample collected \\>24 hours prior to screening\n5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing\n6. Non-compliance to the protocol or the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT02191735', 'acronym': 'C-POC', 'briefTitle': 'RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Response Biomedical Corp.'}, 'officialTitle': 'Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)', 'orgStudyIdInfo': {'id': 'CSP024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Troponin I', 'description': '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.', 'interventionNames': ['Device: RAMP 200', 'Device: RAMP Reader']}, {'label': 'Myoglobin', 'description': '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.', 'interventionNames': ['Device: RAMP 200', 'Device: RAMP Reader']}, {'label': 'CK-MB', 'description': '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.', 'interventionNames': ['Device: RAMP 200', 'Device: RAMP Reader']}, {'label': 'NT-proBNP', 'description': '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.', 'interventionNames': ['Device: RAMP 200', 'Device: RAMP Reader']}], 'interventions': [{'name': 'RAMP 200', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['CK-MB', 'Myoglobin', 'NT-proBNP', 'Troponin I']}, {'name': 'RAMP Reader', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['CK-MB', 'Myoglobin', 'NT-proBNP', 'Troponin I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Medical Research Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Robert H Christenson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Response Biomedical Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}