Chest PainFOVUS-ERNCT02947360
The FOVUS-ER Study: Focused Vascular Ultrasound to Risk Stratify Patients With Chest Pain in the ER
A study testing Focused vascular ultrasound of the carotid arteries in people with Chest Pain and Acute Coronary Syndrome, run by Queen's University at 1 site in Canada.
Trial summary
Broad Goal: To demonstrate that focused vascular ultrasound (FOVUS) can accurately risk stratify patients with chest pain in the emergency department (ED). Background and Rationale: Traditional risk assessment focuses on characteristics of the pain, known Coronary Artery Disease (CAD), risk factors, electrocardiogram… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Carotid Artery Plaque
- What is being tested?
- Focused vascular ultrasound of the carotid arteries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to 17 Dec 2018
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ≥25 years of age;
- Chief complaint of chest pain possibly due to coronary ischemia and requiring cardiac investigations (e.g. ECG, troponin) in the opinion of the treating emergency physician;
- Receiving at least one 12-lead ECG;
- Receiving at least one serum troponin measurement;
- Willing to provide informed consent.
Who cannot join
- Acute ST-segment elevation on the initial ECG;
- Hemodynamic instability;
- High clinical suspicion of pulmonary edema;
- History of recent cocaine or amphetamine use;
- Inability to communicate in English;
- A clear traumatic etiology;
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- Prior enrollment in the study within the past 6 months;
- Terminal non-cardiac illness;
- Previous carotid surgery (endarterectomy or stent);
- Anatomic consideration rendering carotid artery inaccessible (tumor, abscess, scarring, mechanical device).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The FOVUS-ER Study: Focused Vascular Ultrasound to Risk Stratify Patients With Suspected Ischemic Chest Pain in the Emergency Department
Broad Goal: To demonstrate that focused vascular ultrasound (FOVUS) can accurately risk stratify patients with chest pain in the emergency department (ED).
Background and Rationale: Traditional risk assessment focuses on characteristics of the pain, known Coronary Artery Disease (CAD), risk factors, electrocardiogram (ECG), and blood tests to identify active ischemia. Identifying clinically significant CAD remains one of the most challenging tasks in the ED. Current clinical decision rules err on the side of over investigation and admission. To address this limitation, the Investigators have developed a point-of-care carotid ultrasound test predictive of CAD. The Investigators have shown that carotid plaque is strongly associated with significant angiographic CAD in a population referred for angiogram.
Read more
Research Aims:
Primary - To determine the association between carotid plaque measured by a dedicated sonographer and 30-day major adverse cardiac events (MACE), including MI, reperfusion, or death in patients presenting to the ED with suspected cardiac ischemia.
Secondary - To determine the agreement sonographer and emergency physician FOVUS results.
Methodology: The Investigators propose a prospective cohort study to assess the prognostic value of a novel point-of-care carotid ultrasound plaque quantification protocol in the ED of Kingston General Hospital. We will enroll 500 consecutive patients presenting with a chief complaint of chest pain prompting at least one 12-lead ECG and troponin measurement. Patients will undergo carotid scan by a dedicated sonographer and emergency physician. Patients will be followed for MACE for 30 days. Those performing scans will be blinded to clinician's impression and care plans while clinicians will be blinded to FOVUS findings. The primary analysis will involve determination of the sensitivity, sensitivity, positive predictive value, negative predictive value and likelihood ratios associated with FOVUS for 30-day MACE.
Expected Outcomes: The study will provide evidence to determine whether FOVUS may be a useful prognostic tool for emergency physicians assessing patients with suspected ischemic chest pain. The secondary analysis will provide evidence to determine whether emergency physicians can be trained to measure carotid plaque height accurately when compared to the gold standard ultrasonographer measurement.
Significance: If FOVUS can reliably identify very low risk patients, implementation of this novel tool could reduce ED length of stay, monitoring, and overcrowding.
- Conditions
- Chest Pain, Acute Coronary Syndrome, Carotid Artery Plaque
- Being tested
- Focused vascular ultrasound of the carotid arteries
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused vascular ultrasound of the carotid arteriesOther
Also called FOVUS
Emergency physicians and a trained research sonographer will perform a focused vascular ultrasound of the carotids (FOVUS) in patients presenting to the emergency department with chest pain. The diagnostic test characteristics (sensitivity, sensitivity, negative predictive value, positive predictive value and likelihood ratios) for FOVUS carotid plaque height will be determined in relation to our primary outcome (30-day major adverse cardiac events)
| Study group | Role | What they receive |
|---|---|---|
| FOVUS | Experimental | All eligible and consenting patients will receive a focused vascular ultrasound examination of the carotid arteries Receives: Other: Focused vascular ultrasound of the carotid arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Major adverse cardiac events will include acute myocardial infarction (MI),revascularization or mortality
Measured: 30 days
Secondary outcomes (1)
Plaque height measurement during FOVUS
Agreement between ultrasonographers and emergency physicians with respect to plaque height measurement will be calculated using this outcome
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Steven Brooks, Queen's University
- Investigators
- Steven C Brooks, MD, MHSc, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947360
- Sponsor's protocol ID
- EMED-243-16
- Acronym
- FOVUS-ER
- Status last verified
- Jan 2019
- First submitted
- 26 Oct 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brooks SC, Sivilotti MLA, Hetu MF, Norman PA, Day AG, O'Callaghan N, Latiu V, Newbigging J, Hill B, Johri AM. Focused carotid ultrasound to predict major adverse cardiac events among emergency department patients with chest pain. CJEM. 2023 Jan;25(1):81-89. doi: 10.1007/s43678-022-00395-w. Epub 2022 Oct 31.
PubMed 36315347
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FOVUS-ER Study: Focused Vascular Ultrasound to Risk Stratify Patients With Suspected Ischemic Chest Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT02947360
- Acronym / sponsor ID
- FOVUS-ER / EMED-243-16
- Conditions
- Chest Pain, Acute Coronary Syndrome, Carotid Artery Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 27 Oct 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.
Broad Goal: To demonstrate that focused vascular ultrasound (FOVUS) can accurately risk stratify patients with chest pain in the emergency department (ED).
Background and Rationale: Traditional risk assessment focuses on characteristics of the pain, known Coronary Artery Disease (CAD), risk factors, electrocardiogram (ECG), and blood tests to identify active ischemia. Identifying clinically significant CAD remains one of the most challenging tasks in the ED. Current clinical decision rules err on the side of over investigation and admission. To address this limitation, the Investigators have developed a point-of-care carotid ultrasound test predictive of CAD. The Investigators have shown that carotid plaque is strongly associated with significant angiographic CAD in a population referred for angiogram.
Research Aims:
Primary - To determine the association between carotid plaque measured by a dedicated sonographer and 30-day major adverse cardiac events (MACE), including MI, reperfusion, or death in patients presenting to the ED with suspected cardiac ischemia.
Secondary - To determine the agreement sonographer and emergency physician FOVUS results.
Methodology: The Investigators propose a prospective cohort study to assess the prognostic value of a novel point-of-care carotid ultrasound plaque quantification protocol in the ED of Kingston General Hospital. We will enroll 500 consecutive patients presenting with a chief complaint of chest pain prompting at least one 12-lead ECG and troponin measurement. Patients will undergo carotid scan by a dedicated sonographer and emergency physician. Patients will be followed for MACE for 30 days. Those performing scans will be blinded to clinician's impression and care plans while clinicians will be blinded to FOVUS findings. The primary analysis will involve determination of the sensitivity, sensitivity, positive predictive value, negative predictive value and likelihood ratios associated with FOVUS for 30-day MACE.
Expected Outcomes: The study will provide evidence to determine whether FOVUS may be a useful prognostic tool for emergency physicians assessing patients with suspected ischemic chest pain. The secondary analysis will provide evidence to determine whether emergency physicians can be trained to measure carotid plaque height accurately when compared to the gold standard ultrasonographer measurement.
Significance: If FOVUS can reliably identify very low risk patients, implementation of this novel tool could reduce ED length of stay, monitoring, and overcrowding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOVUS | Experimental | Other: Focused vascular ultrasound of the carotid arteriesAll eligible and consenting patients will receive a focused vascular ultrasound examination of the carotid arteries |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women ≥25 years of age;
- Chief complaint of chest pain possibly due to coronary ischemia and requiring cardiac investigations (e.g. ECG, troponin) in the opinion of the treating emergency physician;
- Receiving at least one 12-lead ECG;
- Receiving at least one serum troponin measurement;
- Willing to provide informed consent.
Key exclusion criteria (10 listed)
- Acute ST-segment elevation on the initial ECG;
- Hemodynamic instability;
- High clinical suspicion of pulmonary edema;
- History of recent cocaine or amphetamine use;
- Inability to communicate in English;
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 |
|---|---|---|
| Focused vascular ultrasound of the carotid arteriesAlso: FOVUSEmergency physicians and a trained research sonographer will perform a focused vascular ultrasound of the carotids (FOVUS) in patients presenting to the emergency department with chest pain. The diagnostic test characteristics (sensitivity, sensitivity, negative predictive value, positive predictive value and likelihood ratios) for FOVUS carotid plaque height will be determined in relation to our primary outcome (30-day major adverse cardiac events) | Other | FOVUS |
Primary outcome
Major adverse cardiac events
Time frame: 30 days
Major adverse cardiac events will include acute myocardial infarction (MI),revascularization or mortality
1 secondary outcome
Plaque height measurement during FOVUS
Time frame: At enrollment
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 23 Jan 2019.
- Derived from this study: PubMed 36315347Brooks SC, Sivilotti MLA, Hetu MF, Norman PA, Day AG, O'Callaghan N, Latiu V, Newbigging J, Hill B, Johri AM. Focused carotid ultrasound to predict major adverse cardiac events among emergency department patients with chest pain. CJEM. 2023 Jan;25(1):81-89. doi: 10.1007/s43678-022-00395-w. Epub 2022 Oct 31.
- 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.
Steven C Brooks, MD, MHSc principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused vascular ultrasound of the carotid arteries in people with Chest Pain and Acute Coronary Syndrome, run by Queen's University at 1 site in Canada.
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 5 inclusion and 10 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 23 Jan 2019. 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 Canada. 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?
Major adverse cardiac events (time frame: 30 days). 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 NCT02947360, which also lists 1 linked publication.
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 23 Jan 2019.