Acute Coronary SyndromeC-POCNCT02191735
RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Response Biomedical Corp. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Heart Failure
- What is being tested?
- RAMP 200 and RAMP Reader
- Type of treatment
- Medical device
- How many people
- 719 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Study Arms A - Troponin I (ACS/MI)
- Males or Females, 18 years of age or older, of any race
- Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- Willing to voluntarily agree to sign a consent form (if applicable)
- Study Arms B - Myoglobin (ACS/MI)
- Males or Females, 18 years of age or older, of any race
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- Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.
- Willing to voluntarily agree to sign a consent form (if applicable)
- Study Arms C - CK-MB (ACS/MI)
- Males or Females, 18 years of age or older, of any race
- Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.
- Willing to voluntarily agree to sign a consent form (if applicable)
- Study Arm D - NT-proBNP (HF)
- Males or Females, 18 years of age or older, of any race
- Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines
- Willing to voluntarily agree to sign a consent form (if applicable)
Who cannot join
- Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)
- Healthy Subjects
- Pregnant or lactating
- Subjects not having a cardiac marker test ordered
- Blood sample collected >24 hours prior to screening
- Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
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- Non-compliance to the protocol or the inclusion criteria
- Study Arm D - NT-proBNP (HF)
- Healthy Subjects
- Pregnant or lactating
- Subjects not having a cardiac marker test ordered
- Blood sample collected >24 hours prior to screening
- Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
- Non-compliance to the protocol or the inclusion criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, 55404
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
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.
- Being tested
- RAMP 200, RAMP Reader
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAMP 200Device
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 ReaderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RAMP 200; Device: RAMP Reader | |
| 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. Receives: Device: RAMP 200; Device: RAMP Reader | |
| 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. Receives: Device: RAMP 200; Device: RAMP Reader | |
| 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. Receives: Device: RAMP 200; Device: RAMP Reader |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.
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.
Measured: method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Biomedical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert H Christenson, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191735
- Sponsor's protocol ID
- CSP024
- Acronym
- C-POC
- Status last verified
- Jan 2015
- First submitted
- 10 Jul 2014
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)
- ClinicalTrials.gov ID
- NCT02191735
- Acronym / sponsor ID
- C-POC / CSP024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Response Biomedical Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Troponin I | – | Device: RAMP 200, Device: RAMP ReaderSubjects 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 | – | Device: RAMP 200, Device: RAMP ReaderSubjects 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 | – | Device: RAMP 200, Device: RAMP ReaderSubjects 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 | – | Device: RAMP 200, Device: RAMP ReaderSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (18 listed)
- Study Arms A - Troponin I (ACS/MI)
- Males or Females, 18 years of age or older, of any race
- Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
- Willing to voluntarily agree to sign a consent form (if applicable)
- Study Arms B - Myoglobin (ACS/MI)
Key exclusion criteria (14 listed)
- Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)
- Healthy Subjects
- Pregnant or lactating
- Subjects not having a cardiac marker test ordered
- Blood sample collected >24 hours prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAMP 200The 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 | CK-MB, Myoglobin, NT-proBNP, Troponin I |
| RAMP ReaderThe 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. | Device | CK-MB, Myoglobin, NT-proBNP, Troponin I |
Primary outcome
Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Christenson, PhD principal investigator
University of Maryland, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Response Biomedical Corp. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substantial Equivalence of the RAMP® Reader and the RAMP® 200 when running the RAMP® Cardiac tests. (time frame: method comparison - subjects will be followed for the duration of 1 blood draw, with a total study enrollment over 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.