Acute Myocardial InfarctionPhase 2/3NCT00206830
SHORTness of Breath In the Emergency Department (SHORTIE)
A Phase 2/3 study testing Triage Profiler S.O.B. Panel in people with Acute Myocardial Infarction and Heart Failure, run by Abbott RDx Cardiometabolic at 5 sites in United States.
Trial summary
SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness Of Breath) Panel on patient management, outcome, and cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure, Pulmonary Embolism
- What is being tested?
- Triage Profiler S.O.B. Panel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2005to Aug 2007
- Phase
- Phase 2/3
- 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
Who may be able to join
- Age 18 and older.
- Visit to the ED is due to a primary complaint of shortness of breath alone or shortness of breath with associated chest pain, cough or edema.
Who cannot join
- Blood sample cannot be collected before treatment is initiated, specifically CPR or treatment with i.v. diuretics, injectable anticoagulants, thrombolytics
- Patient is unwilling or unable to give consent to participate in the study
- Patient has renal disease requiring dialysis
- Patients with a clear exacerbation of isolated asthma
- Patients with trauma that interferes with normal breathing function
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New York Methodist Hospital
Brooklyn, New York, 11215
Duke University Hospital Durham
Durham, North Carolina, 27710
Hospital of the Univ. of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stony Brook University Hospital
Stony Brook, New York, 11794
University of Massachusetts Medical Center USA
Worcester, Massachusetts, 01655
About this study
SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness Of Breath) Panel on patient management, outcome, and cost.
Read the detailed description
Patients presenting to the ED with a primary complaint of shortness of breath will a have blood sample collected at enrollment and tested using the Triage® Profiler S.O.B. Panel (measuring creatine kinase MB [CK-MB], myoglobin, troponin I, B-type natriuretic peptide [BNP], D-dimer). The test is used as an aid in the diagnosis of myocardial infarction (MI), an aid in the diagnosis and assessment of severity of heart failure (HF), and an aid in the assessment and evaluation of disseminated intravascular coagulation including pulmonary embolism (PE). Phase I is an observational study and results of the Triage Profiler S.O.B. panel will be blinded to all attending physicians and health care workers. In Phase II, patients will be assigned to either the experimental arm or the control arm of the study. In the experimental arm, the Triage Profiler S.O.B. Panel results will be available to the treating physician and can be incorporated into the decision making process. In the control arm, treating physicians and staff will be blinded to the Triage Profiler S.O.B. Panel results. Time to appropriate treatment, length of ED stay, patient outcome and hospital costs will be assessed in all patients and used to determine the impact of Triage Profiler S.O.B Panel on these parameters. Furthermore, the diagnostic accuracy of the Triage Profiler S.O.B Panel will be calculated.
- Being tested
- Triage Profiler S.O.B. Panel
- Medical subject headings
- Heart Failure, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triage Profiler S.O.B. PanelDevice
| Study group | Role | What they receive |
|---|---|---|
| Control-Blinded from Results | No intervention | Not described |
| Access to Results | Experimental | Not described Receives: Device: Triage Profiler S.O.B. Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to specific treatment for final diagnosis
Length of stay in the emergency department (ED)
ED and total hospital costs
Secondary outcomes (2)
Outcome at 30 days (Phase I and II) and 90 days (Phase II)
Diagnostic accuracy of the Triage® Profiler S.O.B. panel for acute myocardial infarction (AMI), heart failure (HF) and pulmonary embolism (PE) in patients presenting with S.O.B.
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 startApr 2005
- Primary completionAug 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 306 participants
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Investigators
- Alan Maisel, MD, Principal investigator, VA, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206830
- Sponsor's protocol ID
- 011
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2005
- Last updated
- 27 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHORTness of Breath In the Emergency Department (SHORTIE)
- ClinicalTrials.gov ID
- NCT00206830
- Acronym / sponsor ID
- 011
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2007 (actual)
- 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.
SHORTIE is a two-phase study to determine the impact of the Triage Profiler S.O.B. (Shortness Of Breath) Panel on patient management, outcome, and cost.
Detailed description
Patients presenting to the ED with a primary complaint of shortness of breath will a have blood sample collected at enrollment and tested using the Triage® Profiler S.O.B. Panel (measuring creatine kinase MB [CK-MB], myoglobin, troponin I, B-type natriuretic peptide [BNP], D-dimer). The test is used as an aid in the diagnosis of myocardial infarction (MI), an aid in the diagnosis and assessment of severity of heart failure (HF), and an aid in the assessment and evaluation of disseminated intravascular coagulation including pulmonary embolism (PE). Phase I is an observational study and results of the Triage Profiler S.O.B. panel will be blinded to all attending physicians and health care workers. In Phase II, patients will be assigned to either the experimental arm or the control arm of the study. In the experimental arm, the Triage Profiler S.O.B. Panel results will be available to the treating physician and can be incorporated into the decision making process. In the control arm, treating physicians and staff will be blinded to the Triage Profiler S.O.B. Panel results. Time to appropriate treatment, length of ED stay, patient outcome and hospital costs will be assessed in all patients and used to determine the impact of Triage Profiler S.O.B Panel on these parameters. Furthermore, the diagnostic accuracy of the Triage Profiler S.O.B Panel will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Blinded from Results | No intervention | – |
| Access to Results | Experimental | Device: Triage Profiler S.O.B. Panel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 and older.
- Visit to the ED is due to a primary complaint of shortness of breath alone or shortness of breath with associated chest pain, cough or edema.
Key exclusion criteria (5 listed)
- Blood sample cannot be collected before treatment is initiated, specifically CPR or treatment with i.v. diuretics, injectable anticoagulants, thrombolytics
- Patient is unwilling or unable to give consent to participate in the study
- Patient has renal disease requiring dialysis
- Patients with a clear exacerbation of isolated asthma
- Patients with trauma that interferes with normal breathing function
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 Profiler S.O.B. Panel | Device | Access to Results |
Primary outcome
Time to specific treatment for final diagnosis
Length of stay in the emergency department (ED)
ED and total hospital costs
2 secondary outcomes
Outcome at 30 days (Phase I and II) and 90 days (Phase II)
Diagnostic accuracy of the Triage® Profiler S.O.B. panel for acute myocardial infarction (AMI), heart failure (HF) and pulmonary embolism (PE) in patients presenting with S.O.B.
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 27 Jul 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.
Alan Maisel, MD principal investigator
VA, University of California, San Diego
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triage Profiler S.O.B. Panel in people with Acute Myocardial Infarction and Heart Failure, run by Abbott RDx Cardiometabolic at 5 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 5 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 27 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 5 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to specific treatment for final diagnosis. The study lists 3 primary outcomes in all. 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 27 Jul 2015.