Angina, UnstableDispo-ACSNCT00222352
Diagnosis and Treatment of ACS in the ED: The Impact of Rapid Bedside cTnI Testing on Outcomes
An observational study of Angina, Unstable, run by University of Cincinnati at 4 sites in United States.
Trial summary
In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Angina, Unstable
- What is being tested?
- Point of Care cTnL testing
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2004to Mar 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 21 years or older, presenting with symptoms suggestive of acute coronary syndromes, and having cardiac biomarker tests ordered by the treating emergency physician were enrolled. Patients with a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) or a 12-lead ECG diagnostic for acute myocardial infarction were excluded. Patients were enrolled at 4 sites across the United States between December 2004 and November 2006, with final data collection and verification occurring by March 2007.
Who may be able to join
- Age >21 years old
- Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis
Who cannot join
- Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
- Presentation with ECG diagnostic for STEMI
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Jewish Hospital
Cincinnati, Ohio, 45236
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6205
William Beaumont Hospital
Royal Oak, Michigan, 48073
Stanford University
Stanford, California, 94305-6203
About this study
Official title: Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Our hypothesis: point-of-care testing for troponin I will decrease the time for disposition of patients with possible ACS in the emergency setting and decrease the time required for administering appropriate therapies for these patients.
Read the detailed description
Cardiac troponin I is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. It is our hypothesis that having bedside, point-of-care testing for TnI in the ED will decrease time needed to disposition patients to home from the ED or send to the cardiac catheterization laboratory or intensive care setting. Similarly, having point-of-care testing in the ED should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein IIb/IIIa inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive TnI test. This will be evaluated in a randomized, controlled clinical trial of 2000 patients. Half will have the test performed in the ED at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).
- Conditions
- Angina, Unstable
- Being tested
- Point of Care cTnL testing
- Keywords
- Unstable Angina, Non-ST-segment Myocardial Infarction, Myocardial Necrosis, Troponin I
- Medical subject headings
- Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care cTnL testingDiagnostic test
The study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test.
The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half.
| Study group | Role | What they receive |
|---|---|---|
| central laboratory cTnI test | Control Group | |
| Point of Care cTnL testing | Experimental Group Receives: Diagnostic Test: Point of Care cTnL testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disposition from the ED
The primary hypotheses are that i) POC testing using the i-STAT system reduces the time to disposition and discharge for low-risk patients being discharged directly from the ED, and ii) POC testing using the i-STAT system reduces the time to therapy compared to laboratory testing for the subset of patients requiring anti-thrombotic therapies such as heparin/LMW heparin or anti-platelet agents such as GPIIb/IIIa inhibitors or clopidogrel or PCI. These groups of patients (those with new ST-depression, recurrent pain, positive troponin, diabetes, age >65 years, or failed ASA and those discharged without a diagnosis associated with ischemic chest pain) will be extracted from the entire sample. The time from blood draw to initiation of therapy or to disposition and discharge will be computed and compared between the group with POC testing and the group with laboratory testing.
Measured: The time from blood draw to initiation of therapy or to disposition
Secondary outcomes (1)
Time to departure
Measured: time of discharge to home or to the time of transfer to an inpatient setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionNov 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, UnstableStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Jewish Hospital, Cincinnati, Ohio, University of Pennsylvania, Stanford University, Mayo Clinic
- Responsible party
- Principal investigator, Brian Gibler, University of Cincinnati
- Investigators
- Walter B Gibler, MD, Study chair, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222352
- Sponsor's protocol ID
- TJH 04-28
- Acronym
- Dispo-ACS
- Status last verified
- Feb 2018
- First submitted
- 14 Sep 2005
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Blood samples banked for future use. Must be IRB approved before use.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment of Acute Coronary Syndromes in the Emergency Department: The Impact of Rapid Bedside cTnI Testing on Outcomes
- ClinicalTrials.gov ID
- NCT00222352
- Acronym / sponsor ID
- Dispo-ACS / TJH 04-28
- Conditions
- Angina, Unstable
- Keywords
- Unstable Angina, Non-ST-segment Myocardial Infarction, Myocardial Necrosis, Troponin I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Abbott, Jewish Hospital, Cincinnati, Ohio, University of Pennsylvania, Stanford University, Mayo Clinic
- Study start
- Dec 2004 (actual)
- Primary completion
- Nov 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 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.
In a randomized, controlled clinical trial, point-of care testing at the bedside using the cardiac biomarker troponin I in ED patients with possible ACS will be compared to traditional testing of this assay for myocardial necrosis obtained in the central laboratory. Our hypothesis: point-of-care testing for troponin I will decrease the time for disposition of patients with possible ACS in the emergency setting and decrease the time required for administering appropriate therapies for these patients.
Detailed description
Cardiac troponin I is routinely used in the emergency department as a risk stratification tool for detecting myocardial necrosis in patients with possible acute coronary syndrome. It is our hypothesis that having bedside, point-of-care testing for TnI in the ED will decrease time needed to disposition patients to home from the ED or send to the cardiac catheterization laboratory or intensive care setting. Similarly, having point-of-care testing in the ED should decrease the time required to deliver anti-platelet drugs such as aspirin and glycoprotein IIb/IIIa inhibitors and anti-thrombin agents such as heparin to high risk patients found to have a positive TnI test. This will be evaluated in a randomized, controlled clinical trial of 2000 patients. Half will have the test performed in the ED at the bedside (point-of-care) while the other half will receive the usual lab results obtained from the central lab (typically requiring 1.5-2 hours to return).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| central laboratory cTnI test | – | –Control Group |
| Point of Care cTnL testing | – | Diagnostic Test: Point of Care cTnL testingExperimental Group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 21 years or older, presenting with symptoms suggestive of acute coronary syndromes, and having cardiac biomarker tests ordered by the treating emergency physician were enrolled. Patients with a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation) or a 12-lead ECG diagnostic for acute myocardial infarction were excluded. Patients were enrolled at 4 sites across the United States between December 2004 and November 2006, with final data collection and verification occurring by March 2007.
Key inclusion criteria (2 listed)
- Age >21 years old
- Chest pain or other symptoms that lead to drawing cardiac bio-markers for possible ACS diagnosis
Key exclusion criteria (2 listed)
- Presentation with chest pain in the presence of a tachydysrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
- Presentation with ECG diagnostic for STEMI
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 cTnL testingThe study design will be a phase IV prospective, randomized (1:1), parallel-group trial utilizing concurrent controls. The experimental group of interest will be patients receiving the POC cTnI test, and the control group will be patients receiving the central laboratory cTnI test. The treating physician will be blinded to the randomization and will receive only the POC results from half the study patients and only the laboratory results for the remaining half. | Diagnostic test | Point of Care cTnL testing |
Primary outcome
Time to disposition from the ED
Time frame: The time from blood draw to initiation of therapy or to disposition
The primary hypotheses are that i) POC testing using the i-STAT system reduces the time to disposition and discharge for low-risk patients being discharged directly from the ED, and ii) POC testing using the i-STAT system reduces the time to therapy compared to laboratory testing for the subset of patients requiring anti-thrombotic therapies such as heparin/LMW heparin or anti-platelet agents such as GPIIb/IIIa inhibitors or clopidogrel or PCI. These groups of patients (those with new ST-depression, recurrent pain, positive troponin, diabetes, age >65 years, or failed ASA and those discharged without a diagnosis associated with ischemic chest pain) will be extracted from the entire sample. The time from blood draw to initiation of therapy or to disposition and discharge will be computed and compared between the group with POC testing and the group with laboratory testing.
1 secondary outcome
Time to departure
Time frame: time of discharge to home or to the time of transfer to an inpatient setting
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 5 Feb 2018.
- Individual participant dataSharing planned: Undecided. Blood samples banked for future use. Must be IRB approved before use.
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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.
Walter B Gibler, MD study chair
University of Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Unstable, run by University of Cincinnati at 4 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 2 inclusion and 2 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Time to disposition from the ED (time frame: The time from blood draw to initiation of therapy or to disposition). 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 5 Feb 2018.