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2DSPER
Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department
Sponsor study identifier
observational
700
1 country
11
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)Study Completion
September 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2010
Actual (reported)July 15, 2010
Actual (reported)September 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 2014
Actual (reported)September 2014
Actual (reported)Acute coronary syndrome
1 week
Significant coronary artery disease.
1 week
Major adverse cardiac events (MACE - death, MI or revascularization)
6 months
Patients who present to the emergency department with a chief complaint of chest pain and have a moderate pre-test probability for an acute coronary syndrome
Patients presenting to the emergency department with a chief complaint of chest pain
Ha'Emek Medical Center,
Afula, Israel
Soroka University Medical Center
Beersheba, Israel
Hillel Yafe Medical Center
Hadera, Israel
Lady Davis Carmel Medical Center
Haifa, Israel
Hadassah-Hebrew University Medical Center, Mount Scopus
Jerusalem, Israel
Hadassah-University Medical Center, Ein Kerem
Jerusalem, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Shiran A, Blondheim DS, Shimoni S, Jabarren M, Rosenmann D, Sagie A, Leibowitz D, Leitman M, Feinberg MS, Beeri R, Adawi S, Asmer I, Ganaeem M, Friedman Z, Liel-Cohen N. Effect of image quality on accuracy of two-dimensional strain echocardiography for diagnosing ischemic chest pain: a 2DSPER multicenter trial substudy. Int J Cardiovasc Imaging. 2019 Apr;35(4):617-625. doi: 10.1007/s10554-018-1495-x. Epub 2018 Nov 14.
Shiran A, Blondheim DS, Shimoni S, Jabarren M, Rosenmann D, Sagie A, Leibowitz D, Leitman M, Feinberg M, Beeri R, Adawi S, Shotan A, Goland S, Bloch L, Kobal SL, Liel-Cohen N. Two-dimensional strain echocardiography for diagnosing chest pain in the emergency room: a multicentre prospective study by the Israeli echo research group. Eur Heart J Cardiovasc Imaging. 2017 Sep 1;18(9):1016-1024. doi: 10.1093/ehjci/jew168.
Avinoam Shiran, MD
Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology
700 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2010
First Posted
July 15, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Rabin Medical Center
Petah Tikva, Israel
Kaplan Medical Center
Rehovot, Israel
Chaim Sheba Medical Center
Tel Litwinsky, Israel
Assaf Harofeh Medical Center
Zrifin, Israel
Primary Completion
February 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
October 28, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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