Chest PainNCT05785923
Low-Risk Chest Pain Echo Study
A study testing Point-of-Care Echocardiogram in people with Chest Pain, run by University of Kansas Medical Center.
Trial summary
Pilot study to assess if a bedside point-of-care echocardiogram performed on emergency department patients identified as low-risk chest pain prior to discharge significantly changes patient disposition or follow up instructions. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Pain
- What is being tested?
- Point-of-Care Echocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2023to 30 Nov 2023
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults presenting to the emergency department with an isolated chief complaint of chest pain with a HEART score of 3 or less
- Emergency physician of record has decided to discharge this patient from the Emergency Department
Who cannot join
- Patients who are unable to consent for themselves
- History of cardiac transplant or LVAD
- Pediatric patients
- Patients presenting with multiple complaints in addition to chest pain
- Echocardiogram already performed on patient during usual care
- Patients with another non-cardiac admittable diagnosis
- HEART score greater than or equal to 4
Trial locations and contacts
No sites are listed yet.
Lucas Lemar contact
About this study
Official title: The Impact of Point-of-Care Ultrasound Echocardiography on the Disposition of Low-Risk Chest Pain Patients in the Emergency Department
Pilot study to assess if a bedside point-of-care echocardiogram performed on emergency department patients identified as low-risk chest pain prior to discharge significantly changes patient disposition or follow up instructions.
- Conditions
- Chest Pain
- Being tested
- Point-of-Care Echocardiogram
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care EchocardiogramDiagnostic test
Four view ultrasound of the heart performed at the bedside by trained emergency medicine physicians.
| Study group | Role | What they receive |
|---|---|---|
| Echo Arm | Experimental | Chest pain patients identified by their treating physician as being low-risk chest pain will undergo a point-of-care echocardiogram performed by a trained emergency medicine attending or resident prior to discharge from the emergency department. The physician of record will review this ultrasound and it will be documented whether the findings on the ultrasound changed the physician of record's disposition decision for the patient or the follow up instructions or medications. Receives: Diagnostic Test: Point-of-Care Echocardiogram |
| Usual Care | No intervention | Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposition
Will assess if the result of the point-of-care echocardiogram resulted in the physician of record changing subject disposition from discharge to admission. We will assess this by asking the physician of record what the disposition plan is for the patient and recording their answer on IRB approved data collection sheet.
Measured: Day of enrollment
Secondary outcomes (1)
Follow up instructions
Will assess if the result of the point-of-care echocardiogram changed the follow up instructions or discharge medication decision for the enrolled subject as determined by the physician of record by asking them if the echo results caused them to add any additional discharge instructions for the patient. We will record their answer on the IRB approved data collection sheet.
Measured: day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start5 Apr 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne Malik, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785923
- Sponsor's protocol ID
- STUDY00149603
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laureano-Phillips J, Robinson RD, Aryal S, Blair S, Wilson D, Boyd K, Schrader CD, Zenarosa NR, Wang H. HEART Score Risk Stratification of Low-Risk Chest Pain Patients in the Emergency Department: A Systematic Review and Meta-Analysis. Ann Emerg Med. 2019 Aug;74(2):187-203. doi: 10.1016/j.annemergmed.2018.12.010. Epub 2019 Feb 2.
PubMed 30718010Rainer TH, Leung YK, Lee A, Chan PY, Cheng NM, Wong JK, Yan BP, Ahuja AT, Graham CA. Add-on tests for improving risk-stratification in emergency department patients with chest pain who are at low to moderate risk of 30-day major adverse cardiac events. Int J Cardiol. 2016 Oct 1;220:299-306. doi: 10.1016/j.ijcard.2016.05.057. Epub 2016 May 14.
PubMed 27390945Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.
PubMed 33397050Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
PubMed 30413369
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Point-of-Care Ultrasound Echocardiography on the Disposition of Low-Risk Chest Pain Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT05785923
- Acronym / sponsor ID
- STUDY00149603
- Conditions
- Chest Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 27 Mar 2023 (actual)
- 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.
Pilot study to assess if a bedside point-of-care echocardiogram performed on emergency department patients identified as low-risk chest pain prior to discharge significantly changes patient disposition or follow up instructions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echo Arm | Experimental | Diagnostic Test: Point-of-Care EchocardiogramChest pain patients identified by their treating physician as being low-risk chest pain will undergo a point-of-care echocardiogram performed by a trained emergency medicine attending or resident prior to discharge from the emergency department. The physician of record will review this ultrasound and it will be documented whether the findings on the ultrasound changed the physician of record's disposition decision for the patient or the follow up instructions or medications. |
| Usual Care | No intervention | –Chest pain patients identified by their treating physician as being low-risk chest pain will receive the usual care for their condition. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults presenting to the emergency department with an isolated chief complaint of chest pain with a HEART score of 3 or less
- Emergency physician of record has decided to discharge this patient from the Emergency Department
Key exclusion criteria (7 listed)
- Patients who are unable to consent for themselves
- History of cardiac transplant or LVAD
- Pediatric patients
- Patients presenting with multiple complaints in addition to chest pain
- Echocardiogram already performed on patient during usual care
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 EchocardiogramFour view ultrasound of the heart performed at the bedside by trained emergency medicine physicians. | Diagnostic test | Echo Arm |
Primary outcome
Disposition
Time frame: Day of enrollment
Will assess if the result of the point-of-care echocardiogram resulted in the physician of record changing subject disposition from discharge to admission. We will assess this by asking the physician of record what the disposition plan is for the patient and recording their answer on IRB approved data collection sheet.
1 secondary outcome
Follow up instructions
Time frame: day of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 30718010Laureano-Phillips J, Robinson RD, Aryal S, Blair S, Wilson D, Boyd K, Schrader CD, Zenarosa NR, Wang H. HEART Score Risk Stratification of Low-Risk Chest Pain Patients in the Emergency Department: A Systematic Review and Meta-Analysis. Ann Emerg Med. 2019 Aug;74(2):187-203. doi: 10.1016/j.annemergmed.2018.12.010. Epub 2019 Feb 2.
- Background: PubMed 27390945Rainer TH, Leung YK, Lee A, Chan PY, Cheng NM, Wong JK, Yan BP, Ahuja AT, Graham CA. Add-on tests for improving risk-stratification in emergency department patients with chest pain who are at low to moderate risk of 30-day major adverse cardiac events. Int J Cardiol. 2016 Oct 1;220:299-306. doi: 10.1016/j.ijcard.2016.05.057. Epub 2016 May 14.
- Background: PubMed 33397050Guner NG, Yurumez Y, Yucel M, Alacam M, Guner ST, Ercan B. Effects of Point-of-care Ultrasonography on the Diagnostic Process of Patients Admitted to the Emergency Department with Chest Pain: A Randomised Controlled Trial. J Coll Physicians Surg Pak. 2020 Dec;30(12):1262-1268. doi: 10.29271/jcpsp.2020.12.1262.
- Background: PubMed 30413369Buhumaid RE, St-Cyr Bourque J, Shokoohi H, Ma IWY, Longacre M, Liteplo AS. Integrating point-of-care ultrasound in the ED evaluation of patients presenting with chest pain and shortness of breath. Am J Emerg Med. 2019 Feb;37(2):298-303. doi: 10.1016/j.ajem.2018.10.059. Epub 2018 Oct 30.
- Individual participant dataSharing planned: No
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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.
Lucas Lemar contact
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-Care Echocardiogram in people with Chest Pain, run by University of Kansas Medical Center.
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 7 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrienne Malik, MD (913-588-6504, amalik3@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposition (time frame: Day of enrollment). 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 NCT05785923, which also lists 4 linked publications.
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 Mar 2023.