Acute Coronary SyndromePhase 4NCT00206817
Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome (RACE-ACS)
A Phase 4 study testing Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP) in people with Acute Coronary Syndrome, run by Abbott RDx Cardiometabolic at 6 sites in United States.
Trial summary
This clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of cardiac markers in assessing emergency department patients with possible acute coronary syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with possible acute coronary syndrome, 3) determine… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2003to not given
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 21 years at the time of enrollment Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician obtaining an ECG and cardiac markers for the patient's evaluation New onset or worsening symptoms within six hours of presentation to the ED.
Who cannot join
- History of CHF per patient history or in the available medical record. History of end stage renal disease on dialysis. Refused informed consent.4) Refused medical record review and telephone follow up at 30 days and six months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0769
Cleveland Clinic Foundation Dept. of Emergency Medicine
Cleveland, Ohio, 44195
Henry Ford Health Systems
Detroit, Michigan, 48202
UC Davis Medical Center
Sacramento, California, 95817
Wake Forest Univ. Baptist Med. Center
Winston-Salem, North Carolina, 27157
About this study
This clinical trial is being conducted to 1) evaluate the possible usefulness of a panel of cardiac markers in assessing emergency department patients with possible acute coronary syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with possible acute coronary syndrome, 3) determine if BNP can be used to predict adverse events during hospitalization and in the emergency department, and 4) evaluate how a Point-of-Care testing platform affects resource utilization in the emergency department.
Read the detailed description
The correct diagnosis of acute coronary syndrome (ACS) remains a frequent significant challenge for emergency physicians. Over eight million chest pain patients present annually and despite promising advances in diagnosis, over four percent of ACS patients are mistakenly discharged home. While the history and physical, cardiac risk factor assessment, ECG, and cardiac marker determination are all included in the assessment and risk stratification of patients presenting with possible ACS, this assessment is clearly far from perfect. Improved rapid and accurate means of assessment in this population in the ED are clearly needed.ED patients with chest discomfort will be screened and approached for study enrollment. Consenting patients meeting the study inclusion and exclusion criteria will be enrolled. Point-of-care serial cardiac marker measurements will be performed. Based on a web-based computerized randomization system, half (50%) the patients willundergo routine central laboratory testing only. Half (50%) of the patients will undergopoint-of-care markers performed in the ED in addition to routine central laboratory testing.In this second group, central laboratory test results will be blinded from the ED physicianuntil the disposition time. BNP will be blinded and not reported to physicians for the first 500 patients (Phase I). After the first 500 patients have been enrolled, an interim analysis will be performed to determine the clinical utility of BNP in patient assessment. After physician education of these results, the trial will resume for the remaining 500 patients (Phase II). In Phase II, BNP levels will be provided to the physicians using the same time and randomization format.The patients and their medical records will be followed for a period of thirty days and sixmonths after enrollment.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)
- 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.
Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the three-marker versus the four-marker panelDetermine the added benefit of BNP in the diagnosis of patients with ACS
Secondary outcomes (1)
Determine the economic and resource utilization benefit of the POC platform vs. standard lab testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Investigators
- Andra L Blomkalns, MD, Principal investigator, University of Cinncinati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206817
- Sponsor's protocol ID
- 020
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2005
- Last updated
- 21 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Assessment of Cardiac Markers for the Evaluation of Acute Coronary Syndrome (RACE-ACS)
- ClinicalTrials.gov ID
- NCT00206817
- Acronym / sponsor ID
- 020
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 21 Sep 2005 (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 trial is being conducted to 1) evaluate the possible usefulness of a panel of cardiac markers in assessing emergency department patients with possible acute coronary syndrome, 2) evaluate the usefulness of BNP in assessing emergency department patients with possible acute coronary syndrome, 3) determine if BNP can be used to predict adverse events during hospitalization and in the emergency department, and 4) evaluate how a Point-of-Care testing platform affects resource utilization in the emergency department.
Detailed description
The correct diagnosis of acute coronary syndrome (ACS) remains a frequent significant challenge for emergency physicians. Over eight million chest pain patients present annually and despite promising advances in diagnosis, over four percent of ACS patients are mistakenly discharged home. While the history and physical, cardiac risk factor assessment, ECG, and cardiac marker determination are all included in the assessment and risk stratification of patients presenting with possible ACS, this assessment is clearly far from perfect. Improved rapid and accurate means of assessment in this population in the ED are clearly needed.ED patients with chest discomfort will be screened and approached for study enrollment. Consenting patients meeting the study inclusion and exclusion criteria will be enrolled. Point-of-care serial cardiac marker measurements will be performed. Based on a web-based computerized randomization system, half (50%) the patients willundergo routine central laboratory testing only. Half (50%) of the patients will undergopoint-of-care markers performed in the ED in addition to routine central laboratory testing.In this second group, central laboratory test results will be blinded from the ED physicianuntil the disposition time. BNP will be blinded and not reported to physicians for the first 500 patients (Phase I). After the first 500 patients have been enrolled, an interim analysis will be performed to determine the clinical utility of BNP in patient assessment. After physician education of these results, the trial will resume for the remaining 500 patients (Phase II). In Phase II, BNP levels will be provided to the physicians using the same time and randomization format.The patients and their medical records will be followed for a period of thirty days and sixmonths after enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age greater than or equal to 21 years at the time of enrollment Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician obtaining an ECG and cardiac markers for the patient's evaluation New onset or worsening symptoms within six hours of presentation to the ED.
Key exclusion criteria (1 listed)
- History of CHF per patient history or in the available medical record. History of end stage renal disease on dialysis. Refused informed consent.4) Refused medical record review and telephone follow up at 30 days and six months.
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 |
|---|---|---|
| Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP) | Device | – |
Primary outcome
Sensitivity and specificity of the three-marker versus the four-marker panelDetermine the added benefit of BNP in the diagnosis of patients with ACS
1 secondary outcome
Determine the economic and resource utilization benefit of the POC platform vs. standard lab testing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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AI-Assisted Interpretation of Cardiac CT in the Emergency Department
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Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
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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.
Andra L Blomkalns, MD principal investigator
University of Cinncinati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triage CardioProfilER (Troponin I, Myoglobin, CK-MB, BNP) in people with Acute Coronary Syndrome, run by Abbott RDx Cardiometabolic at 6 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Sensitivity and specificity of the three-marker versus the four-marker panelDetermine the added benefit of BNP in the diagnosis of patients with ACS. 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 21 Jul 2015.