RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
NCT ID: NCT02191735
Last Updated: 2015-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
719 participants
OBSERVATIONAL
2014-07-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
NCT01381172
Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure
NCT02145351
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study
NCT00500838
Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)
NCT00206856
ECG Belt vs. Echocardiographic Optimization of CRT
NCT03305692
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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)
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Response Biomedical Corp.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert H Christenson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Francisco General Hospital
San Francisco, California, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CSP024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.