2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room (2DSPER)
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|ClinicalTrials.gov Identifier: NCT01163019|
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : October 28, 2014
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.
|Condition or disease|
|Chest Pain Coronary Artery Disease Acute Coronary Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||700 participants|
|Official Title:||Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||September 2014|
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
- Acute coronary syndrome [ Time Frame: 1 week ]
- Significant coronary artery disease. [ Time Frame: 1 week ]
- Major adverse cardiac events (MACE - death, MI or revascularization) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163019
|Ha'Emek Medical Center,|
|Soroka University Medical Center|
|Beer Sheva, Israel|
|Hillel Yafe Medical Center|
|Lady Davis Carmel Medical Center|
|Hadassah-Hebrew University Medical Center, Mount Scopus|
|Hadassah-University Medical Center, Ein Kerem|
|Shaare Zedek Medical Center|
|Rabin Medical Center|
|Petah Tikva, Israel|
|Kaplan Medical Center|
|Chaim Sheba Medical Center|
|Tel Hashomer, Israel|
|Assaf Harofeh Medical Center|
|Principal Investigator:||Avinoam Shiran, MD||Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology|