Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01163019
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2010-07-12
Brief Title:
2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room
Sponsor:
Technion Israel Institute of Technology
Organization:
Technion Israel Institute of Technology
Study Overview
Official Title:
Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2014-10
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:
2DSPER
Brief Summary:
Background Chest pain CP and suspected heart attack is the second most frequent complaint among patients presenting to the emergency department ED Present workup involves in-hospital observation for 6 - 48 hours and requires significant resources including imaging tests some of which are invasive and involve radiation and radio-contrast agents which can be toxic to the kidney
CP can result from impaired blood supply to the heart muscle which may result in impaired contraction of the heart that persists for several days Bedside echocardiography with semi-automated speckle tracking strain analysis 2D strain is a novel promising noninvasive tool for the evaluation of heart muscle contraction 2D strain can be useful for evaluating patients with CP since it can accurately detect minor impairment in heart muscle contraction that can identify patients with coronary artery disease CAD and impending heart attack coronary arteries are the arteries supplying blood to the heart muscle
Working hypothesis and aims The investigators hypothesize that a bedside echo study with normal 2D strain may allow quick and safe ruling out of a heart attack and significant CAD disease as the cause of CP
The main aim of the study is to validate the investigators preliminary findings in a large number of patients in order to establish whether a normal 2D strain can safely rule out a heart attack or life threatening CAD
Methods In a large multi-center study 1200 patients presenting to the ED with acute CP of an unclear cause will undergo echocardiography as close as possible to presentation and not more than 24 hours from cessation of pain Patients will undergo standard workup by the ED physicians Standard echocardiographic findings but not the 2D strain analysis will be made available to the attending physician Data from discharge letters ECGs blood tests stress tests nuclear imaging heart CT and heart catheterization will be collected A 6-month follow-up telephone interview will be performed to collect data on survival heart attacks re-hospitalization and revascularization opening heart vessels blockages 2D strain analysis will be performed off-line in a central laboratory to evaluate the ability of 2D strain to distinguish between patients with CP from heart disease and patients without life threatening heart disease that can be early released home safely
Expected results The investigators expect based on the investigators previous experience that patients with normal 2D strain will have a very low probability of a heart attack and significant CAD The investigators further expect these patients to have an excellent 6-month prognosis This will allow their early and cost-effective discharge
Importance and Probable implications to Medicine Reduction in ED patient load and a decrease in unnecessary hospitalizations for CP Cost and resource savings and elimination of unnecessary imaging studies some of which are invasive or involve radiation and contrast agents
CP can result from impaired blood supply to the heart muscle which may result in impaired contraction of the heart that persists for several days Bedside echocardiography with semi-automated speckle tracking strain analysis 2D strain is a novel promising noninvasive tool for the evaluation of heart muscle contraction 2D strain can be useful for evaluating patients with CP since it can accurately detect minor impairment in heart muscle contraction that can identify patients with coronary artery disease CAD and impending heart attack coronary arteries are the arteries supplying blood to the heart muscle
Working hypothesis and aims The investigators hypothesize that a bedside echo study with normal 2D strain may allow quick and safe ruling out of a heart attack and significant CAD disease as the cause of CP
The main aim of the study is to validate the investigators preliminary findings in a large number of patients in order to establish whether a normal 2D strain can safely rule out a heart attack or life threatening CAD
Methods In a large multi-center study 1200 patients presenting to the ED with acute CP of an unclear cause will undergo echocardiography as close as possible to presentation and not more than 24 hours from cessation of pain Patients will undergo standard workup by the ED physicians Standard echocardiographic findings but not the 2D strain analysis will be made available to the attending physician Data from discharge letters ECGs blood tests stress tests nuclear imaging heart CT and heart catheterization will be collected A 6-month follow-up telephone interview will be performed to collect data on survival heart attacks re-hospitalization and revascularization opening heart vessels blockages 2D strain analysis will be performed off-line in a central laboratory to evaluate the ability of 2D strain to distinguish between patients with CP from heart disease and patients without life threatening heart disease that can be early released home safely
Expected results The investigators expect based on the investigators previous experience that patients with normal 2D strain will have a very low probability of a heart attack and significant CAD The investigators further expect these patients to have an excellent 6-month prognosis This will allow their early and cost-effective discharge
Importance and Probable implications to Medicine Reduction in ED patient load and a decrease in unnecessary hospitalizations for CP Cost and resource savings and elimination of unnecessary imaging studies some of which are invasive or involve radiation and contrast agents
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