2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room

NCT01163019 | Completed

• 1 other identifier: 2DS-CP-ED-MSS-IERG
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 11

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.

Conditions

Chest Pain; Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Chest pain; acute coronary syndrome; Emergency department; speckle tracking imaging; 2D strain; Echocardiography

Outcome Measures

Primary Outcomes (2)

• Acute coronary syndrome

  1 week

• Significant coronary artery disease.

  1 week

Secondary Outcomes (1)

• Major adverse cardiac events (MACE - death, MI or revascularization)

  6 months

Study Arms (1)

Chest pain

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the emergency department with a chief complaint of chest pain

You may qualify if:

• Patients presenting to the emergency department with chest pain characteristic for ischemia and suspected acute coronary syndrome and at least one of the following:
• Planned emergency department or chest pain unit observation for at least 6 hours
• Hospital or chest pain unit admission for suspected acute coronary syndrome
• Planned coronary CT scan
• Age ≥ 45 years old
• Normal sinus rhythm
• Patient able to give an informed consent

You may not qualify if:

• ST elevation MI (≥ 1mm in at least 2 contiguous leads) or unstable patients requiring urgent care
• Significant (≥ 1mm ST depression in at least 2 contiguous leads) on initial ECG
• Elevated troponin on first examination
• History of previous MI, CABG, significant Q waves on ECG or wall motion abnormality on a previous echo
• Atrial fibrillation or abundant arrhythmia
• CLBBB, Ventricular pacing
• Valvular disease of at least moderate severity
• Cardiomyopathy
• Abnormal septal motion due to right ventricular disease or lung disease
• Technically suboptimal echo study (\> 2 segments of suboptimal quality from apical views)
• Pregnancy
• Inadequate strain tracing

Sponsors & Collaborators

• Technion, Israel Institute of Technology: lead

Study Sites (11)

Ha'Emek Medical Center,

Afula, Israel

Location

Soroka University Medical Center

Beersheba, Israel

Location

Hillel Yafe Medical Center

Hadera, Israel

Location

Lady Davis Carmel Medical Center

Haifa, Israel

Location

Hadassah-Hebrew University Medical Center, Mount Scopus

Jerusalem, Israel

Location

Hadassah-University Medical Center, Ein Kerem

Jerusalem, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

Assaf Harofeh Medical Center

Zrifin, Israel

Location

Related Publications (2)

• 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.

  PMID: 30430326 DERIVED

• 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.

  PMID: 27566720 DERIVED

MeSH Terms

Conditions

Chest Pain; Coronary Artery Disease; Acute Coronary Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Avinoam Shiran, MD

  Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Echocardiography, Lady Davis Carmel Medical Center

Study Record Dates

• First Submitted: July 12, 2010
• First Posted: July 15, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

IL (11)