Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02947360
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2016-10-26
Brief Title:
The FOVUS-ER Study Focused Vascular Ultrasound to Risk Stratify Patients With Chest Pain in the ER
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
The FOVUS-ER Study Focused Vascular Ultrasound to Risk Stratify Patients With Suspected Ischemic Chest Pain in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOVUS-ER
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 clinicians 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
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 clinicians 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None