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

Sponsor
Queen's University (Other)
Overall Status
Completed
CT.gov ID
NCT02947360
Collaborator
(none)
326
1
1
25.5
12.8

Study Details

Study Description

Brief 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 (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.

Condition or Disease Intervention/Treatment Phase
  • Other: Focused vascular ultrasound of the carotid arteries
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
326 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The FOVUS-ER Study: Focused Vascular Ultrasound to Risk Stratify Patients With Suspected Ischemic Chest Pain in the Emergency Department
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Dec 17, 2018
Actual Study Completion Date :
Dec 17, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiac events [30 days]

      Major adverse cardiac events will include acute myocardial infarction (MI),revascularization or mortality

    Secondary Outcome Measures

    1. Plaque height measurement during FOVUS [At enrollment]

      Agreement between ultrasonographers and emergency physicians with respect to plaque height measurement will be calculated using this outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen's University Kingston Ontario Canada K7L 2V7

    Sponsors and Collaborators

    • Queen's University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Steven Brooks, Associate Professor, Principal Investigator, Queen's University
    ClinicalTrials.gov Identifier:
    NCT02947360
    Other Study ID Numbers:
    • EMED-243-16
    First Posted:
    Oct 27, 2016
    Last Update Posted:
    Jan 23, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 23, 2019