Chest PainNCT02719509
Emergency Department Cardiac Ultrasound
An observational study of Chest Pain and Dyspnea, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
This is a prospective observational study evaluating the diagnostic utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Dyspnea
- What is being tested?
- Cardiac Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with undifferentiated chest pain or shortness of breath who have a cardiac ultrasound ordered by the emergency provider as part of the diagnostic workup
Who may be able to join
- ED patients with a chief complaint of chest pain or shortness of breath
- Cardiac Ultrasound ordered by provider as part of diagnostic workup
Who cannot join
- All providers have already reviewed the ultrasound images (unable to obtained pre- ultrasound assessment)
- Age < 18
- Known to be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Prospective Evaluation of the Utility of Bedside Cardiac Ultrasound for Undifferentiated Chest Pain and Shortness of Breath in the Emergency Department
This is a prospective observational study evaluating the diagnostic utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Emergency department providers will be interviewed before and after the completion of a cardiac ultrasound to determine if the ultrasound resulted in any changes in management. Other outcomes include determination of incidence of unexpected findings.
Read the detailed description
Bedside cardiac ultrasound is performed regularly in the emergency department to assess patients who present with undifferentiated chest pain or shortness of breath. Utility of cardiac ultrasound in this setting is emerging as standard of care. Cardiac ultrasound can rapidly provide essential information about the presence or absence of multiple cardiopulmonary pathologies. Cardiac ultrasound is safe, immediately accessible, and gives providers data regarding their patients in real-time.
While cardiac ultrasound is common practice in emergency departments, the diagnostic utility of this test has been difficult to study. There are few studies in the literature that describe its utility in evaluating specific diagnoses. These studies have evaluated the use of cardiac ultrasound in diagnosing acute cardiogenic pulmonary edema, aortic dilation/aneurysm, acute coronary syndrome, and acute heart failure.
The purpose of this study is to evaluate the utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. This study will evaluate several parameters including how the cardiac ultrasound contributes to provider's management plan and assessment of the patient's diagnosis.
This is a prospective observational study design. The investigators will prospectively enroll eligible consecutive patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Patients will be included if a provider has ordered (or is planning on ordering) a cardiac ultrasound as part of the patient's diagnostic workup. Research associates will screen for these two chief complaints and will then approach the ED provider and ask if they ordered or are planning to order a cardiac ultrasound. ED providers may also contact research associates to enroll patients that meet the study criteria.
Pre-ultrasound assessment: After eligibility is determined, a research associate will approach the provider directly involved in the patient's care (Resident or Staff). The provider completing the data collection forms does not need to be the provider who ordered or performed the ultrasound. The provider completing the forms will be an Emergency Medicine 2nd year level resident or above. The provider filling out the data collection form will fill out the pre-ultrasound assessment prior to reviewing the cardiac ultrasound images (either in real-time or on the computer after the ultrasound is completed). The provider will fill out a data collection form that asks about the most likely diagnosis, expected ultrasound findings, and current management plan.
After the ultrasound is completed the same provider will be asked about the most likely diagnosis, observed ultrasound findings, and any new management changes.
Other clinical data that will be collected will include demographic data, vital signs, relevant co-morbidities, imaging results, and lab results from the emergency department visit.
- Conditions
- Chest Pain, Dyspnea
- Being tested
- Cardiac Ultrasound
- Medical subject headings
- Chest Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac UltrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | All emergency department patients who had a cardiac ultrasound performed as part of their diagnostic workup Receives: Procedure: Cardiac Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of management changes
Approximate duration of the emergency department visit
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Klein, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719509
- Sponsor's protocol ID
- HSR # 15-4092
- Status last verified
- Aug 2016
- First submitted
- 4 Feb 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Utility of Bedside Cardiac Ultrasound for Undifferentiated Chest Pain and Shortness of Breath in the Emergency Department
- ClinicalTrials.gov ID
- NCT02719509
- Acronym / sponsor ID
- HSR # 15-4092
- Conditions
- Chest Pain, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Mar 2016 (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 is a prospective observational study evaluating the diagnostic utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Emergency department providers will be interviewed before and after the completion of a cardiac ultrasound to determine if the ultrasound resulted in any changes in management. Other outcomes include determination of incidence of unexpected findings.
Detailed description
Bedside cardiac ultrasound is performed regularly in the emergency department to assess patients who present with undifferentiated chest pain or shortness of breath. Utility of cardiac ultrasound in this setting is emerging as standard of care. Cardiac ultrasound can rapidly provide essential information about the presence or absence of multiple cardiopulmonary pathologies. Cardiac ultrasound is safe, immediately accessible, and gives providers data regarding their patients in real-time.
While cardiac ultrasound is common practice in emergency departments, the diagnostic utility of this test has been difficult to study. There are few studies in the literature that describe its utility in evaluating specific diagnoses. These studies have evaluated the use of cardiac ultrasound in diagnosing acute cardiogenic pulmonary edema, aortic dilation/aneurysm, acute coronary syndrome, and acute heart failure.
The purpose of this study is to evaluate the utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. This study will evaluate several parameters including how the cardiac ultrasound contributes to provider's management plan and assessment of the patient's diagnosis.
This is a prospective observational study design. The investigators will prospectively enroll eligible consecutive patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Patients will be included if a provider has ordered (or is planning on ordering) a cardiac ultrasound as part of the patient's diagnostic workup. Research associates will screen for these two chief complaints and will then approach the ED provider and ask if they ordered or are planning to order a cardiac ultrasound. ED providers may also contact research associates to enroll patients that meet the study criteria.
Pre-ultrasound assessment: After eligibility is determined, a research associate will approach the provider directly involved in the patient's care (Resident or Staff). The provider completing the data collection forms does not need to be the provider who ordered or performed the ultrasound. The provider completing the forms will be an Emergency Medicine 2nd year level resident or above. The provider filling out the data collection form will fill out the pre-ultrasound assessment prior to reviewing the cardiac ultrasound images (either in real-time or on the computer after the ultrasound is completed). The provider will fill out a data collection form that asks about the most likely diagnosis, expected ultrasound findings, and current management plan.
After the ultrasound is completed the same provider will be asked about the most likely diagnosis, observed ultrasound findings, and any new management changes.
Other clinical data that will be collected will include demographic data, vital signs, relevant co-morbidities, imaging results, and lab results from the emergency department visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Procedure: Cardiac UltrasoundAll emergency department patients who had a cardiac ultrasound performed as part of their diagnostic workup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with undifferentiated chest pain or shortness of breath who have a cardiac ultrasound ordered by the emergency provider as part of the diagnostic workup
Key inclusion criteria (2 listed)
- ED patients with a chief complaint of chest pain or shortness of breath
- Cardiac Ultrasound ordered by provider as part of diagnostic workup
Key exclusion criteria (3 listed)
- All providers have already reviewed the ultrasound images (unable to obtained pre- ultrasound assessment)
- Age < 18
- Known to be pregnant
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 |
|---|---|---|
| Cardiac Ultrasound | Procedure or surgery | Observational Cohort |
Primary outcome
Incidence of management changes
Time frame: 6 hours
Approximate duration of the emergency department visit
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 26 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Chest Pain
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CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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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.
Lauren Klein, MD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Dyspnea, run by Hennepin Healthcare Research Institute 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 3 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 26 Aug 2016. 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.
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?
Incidence of management changes (time frame: 6 hours). 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 26 Aug 2016.