The FOVUS-ER Study: Focused Vascular Ultrasound to Risk Stratify Patients With Chest Pain in the ER (FOVUS-ER)

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.

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 Overview

• Status: Completed
• Conditions: Chest Pain; Carotid Artery Plaque; Acute Coronary Syndrome
• Intervention / Treatment: Other: Focused vascular ultrasound of the carotid arteries

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Queen's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women ≥25 years of age;
2. 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;
3. Receiving at least one 12-lead ECG;
4. Receiving at least one serum troponin measurement;
5. Willing to provide informed consent.

Exclusion Criteria:

1. Acute ST-segment elevation on the initial ECG;
2. Hemodynamic instability;
3. High clinical suspicion of pulmonary edema;
4. History of recent cocaine or amphetamine use;
5. Inability to communicate in English;
6. A clear traumatic etiology;
7. Prior enrollment in the study within the past 6 months;
8. Terminal non-cardiac illness;
9. Previous carotid surgery (endarterectomy or stent);
10. Anatomic consideration rendering carotid artery inaccessible (tumor, abscess, scarring, mechanical device).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: FOVUS; All eligible and consenting patients will receive a focused vascular ultrasound examination of the carotid arteries

Other: Focused vascular ultrasound of the carotid arteries; 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); Other Names: FOVUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	Major adverse cardiac events will include acute myocardial infarction (MI),revascularization or mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque height measurement during FOVUS	Agreement between ultrasonographers and emergency physicians with respect to plaque height measurement will be calculated using this outcome	At enrollment

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Steven C Brooks, MD, MHSc, Queen's University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): December 17, 2018
• Study Completion (ACTUAL): December 17, 2018

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (ESTIMATE): October 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Carotid Artery Diseases; Chest Pain; Carotid Stenosis; Acute Coronary Syndrome
• Other Study ID Numbers: EMED-243-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO