Acute Coronary SyndromePhase 4RACENCT01563250
Improving the Management of Acute Coronary Syndromes in the Emergency Department
A Phase 4 study testing Point of Care testing in people with Acute Coronary Syndrome, run by Integrated Medical Research LLC at 1 site in United States.
Trial summary
By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Point of Care testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 4
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chief complaint of chest pain
- 35 years old or greater
Who cannot join
- ST elevation MI
- New Left Bundle Branch Block
- Admission regardless of test result
- Leaving ED against medical advice
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Methodist Hospital
Brooklyn, New York, 11215
About this study
Official title: Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway
By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Point of Care testing
- Keywords
- Acute Coronary Syndrome, Cardiac Biomarkers, point of care testing
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care testingDevice
Also called Triage Cardiac Panel by Alere
The investigators will implement 6 months of randomized testing periods, 2 weeks each. During this 2 week block, cardiac biomarkers will be tested at the bedside in the ED using the Triage Cardiac Panel that will test for CK-MB, Myoglobin, and Troponin I.
Each blood sample that is take for point of care testing will be saved. The plasma from the saved sample will be frozen and the sample will be sent to an off-site testing center for high sensitivity troponin testing.
All patients will be followed at the 30-day mark and those patients who are discharged home from the ED will be followed within 48 hours as well.
| Study group | Role | What they receive |
|---|---|---|
| Core Laboratory | No intervention | Patients receiving serial routinely available cardiac biomarker testing in a core laboratory setting using Troponin T. (Roche Centaur) |
| Point of Care | Active comparator | Patients will receive the Point of Care testing intervention using serial cardiac biomarker testing at the bedside including myoglobin, Troponin I and CK-MB. (Triage Cardiac Panel, Alere) Receives: Device: Point of Care testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED length of stay
From patient check-in time to patient admit or discharge time
Measured: Average of 3 hours stay in the Emergency Department
Secondary outcomes (2)
Mortality rate of admitted patients
Average hospital stay 3 days.
Measured: During hospital admission and at 30 days
Hospital Admission Rate
Observing the rate at which physicians admit patients to the hospital.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrated Medical Research LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Alere San Diego, New York State Department of Health
- Responsible party
- Principal investigator, Robert Birkhahn, MD, Integrated Medical Research LLC
- Investigators
- Bethany A Byrd, D.O., Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563250
- Sponsor's protocol ID
- IMR-001
- Acronym
- RACE
- Status last verified
- Apr 2013
- First submitted
- 9 Jun 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Birkhahn RH, Haines E, Wen W, Reddy L, Briggs WM, Datillo PA. Estimating the clinical impact of bringing a multimarker cardiac panel to the bedside in the ED. Am J Emerg Med. 2011 Mar;29(3):304-8. doi: 10.1016/j.ajem.2009.12.007. Epub 2010 Apr 2.
PubMed 20825823
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway
- ClinicalTrials.gov ID
- NCT01563250
- Acronym / sponsor ID
- RACE / IMR-001
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Cardiac Biomarkers, point of care testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Integrated Medical Research LLCUniversity, hospital or other
- Collaborators
- Alere San Diego, New York State Department of Health
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Mar 2012 (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.
By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Laboratory | No intervention | –Patients receiving serial routinely available cardiac biomarker testing in a core laboratory setting using Troponin T. (Roche Centaur) |
| Point of Care | Active comparator | Device: Point of Care testingPatients will receive the Point of Care testing intervention using serial cardiac biomarker testing at the bedside including myoglobin, Troponin I and CK-MB. (Triage Cardiac Panel, Alere) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chief complaint of chest pain
- 35 years old or greater
Key exclusion criteria (4 listed)
- ST elevation MI
- New Left Bundle Branch Block
- Admission regardless of test result
- Leaving ED against medical advice
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 |
|---|---|---|
| Point of Care testingAlso: Triage Cardiac Panel by AlereThe investigators will implement 6 months of randomized testing periods, 2 weeks each. During this 2 week block, cardiac biomarkers will be tested at the bedside in the ED using the Triage Cardiac Panel that will test for CK-MB, Myoglobin, and Troponin I. Each blood sample that is take for point of care testing will be saved. The plasma from the saved sample will be frozen and the sample will be sent to an off-site testing center for high sensitivity troponin testing. All patients will be followed at the 30-day mark and those patients who are discharged home from the ED will be followed within 48 hours as well. | Device | Point of Care |
Primary outcome
ED length of stay
Time frame: Average of 3 hours stay in the Emergency Department
From patient check-in time to patient admit or discharge time
2 secondary outcomes
Mortality rate of admitted patients
Time frame: During hospital admission and at 30 days
Hospital Admission Rate
Time frame: Baseline
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 4 Apr 2013.
- Background: PubMed 20825823Birkhahn RH, Haines E, Wen W, Reddy L, Briggs WM, Datillo PA. Estimating the clinical impact of bringing a multimarker cardiac panel to the bedside in the ED. Am J Emerg Med. 2011 Mar;29(3):304-8. doi: 10.1016/j.ajem.2009.12.007. Epub 2010 Apr 2.
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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.
Bethany A Byrd, D.O. principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Point of Care testing in people with Acute Coronary Syndrome, run by Integrated Medical Research LLC at 1 site 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 2 inclusion and 4 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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ED length of stay (time frame: Average of 3 hours stay in the Emergency Department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563250, which also lists 1 linked publication.
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 4 Apr 2013.