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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Technion, Israel Institute of Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Avinoam Shiran, Technion, Israel Institute of Technology
ClinicalTrials.gov Identifier:
NCT01163019
First received: July 12, 2010
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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
Chest Pain
Coronary Artery Disease
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Technion, Israel Institute of Technology:

Primary Outcome Measures:
  • Acute coronary syndrome [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Significant coronary artery disease. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major adverse cardiac events (MACE - death, MI or revascularization) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: September 2010
Groups/Cohorts
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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. 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
  2. Age ≥ 45 years old
  3. Normal sinus rhythm
  4. Patient able to give an informed consent

Exclusion Criteria:

  1. ST elevation MI (≥ 1mm in at least 2 contiguous leads) or unstable patients requiring urgent care
  2. Significant (≥ 1mm ST depression in at least 2 contiguous leads) on initial ECG
  3. Elevated troponin on first examination
  4. History of previous MI, CABG, significant Q waves on ECG or wall motion abnormality on a previous echo
  5. Atrial fibrillation or abundant arrhythmia
  6. CLBBB, Ventricular pacing
  7. Valvular disease of at least moderate severity
  8. Cardiomyopathy
  9. Abnormal septal motion due to right ventricular disease or lung disease
  10. Technically suboptimal echo study (> 2 segments of suboptimal quality from apical views)
  11. Pregnancy
  12. Inadequate strain tracing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163019

Contacts
Contact: Avinoam Shiran, MD 972-4-825-0507 shiran_avinoam@clalit.org.il
Contact: Noah Liel-Cohen, MD lielnoah@bgu.ac.il

Locations
Israel
Ha'Emek Medical Center, Recruiting
Afula, Israel
Contact: Mohamed Jabaren, MD       jabaren_mo@clalit.org.il   
Principal Investigator: Mohamed Jabaren, MD         
Soroka University Medical Center Recruiting
Beer Sheva, Israel
Contact: Noah Liel-Cohen, MD       lielnoah@bgu.ac.il   
Principal Investigator: Noah Liel-Cohen, MD         
Hillel Yafe Medical Center Recruiting
Hadera, Israel
Contact: David Blondheim, MD       davidb@hy.health.gov.il   
Principal Investigator: David Blondheim, MD         
Lady Davis Carmel Medical Center Recruiting
Haifa, Israel
Contact: Avinoam Shiran, MD       shiran_avinoam@clalit.org.il   
Principal Investigator: Avinoam Shiran, MD         
Hadassah-Hebrew University Medical Center, Mount Scopus Recruiting
Jerusalem, Israel
Contact: David Leibowitz, MD       OLEIBO@hadassah.org.il   
Principal Investigator: David Leibowitz, MD         
Hadassah-University Medical Center, Ein Kerem Recruiting
Jerusalem, Israel
Contact: Ronen Beeri, MD       beeri@hadassah.org.il   
Principal Investigator: Ronen Beeri, MD         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: David Rosenman, MD       rosenman@netvision.net.il   
Principal Investigator: David Rosenman, MD         
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Alex Sagie, ND       asagie@post.tau.ac.il   
Principal Investigator: Alex Sagie, MD         
Kaplan Medical Center Recruiting
Rehovot, Israel
Contact: Sara Shimoni, MD       sara_s@clalit.org.il   
Principal Investigator: Sara Shimoni, MD         
Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Micha S Feinberg, MD       micha.feinberg@sheba.health.gov.il   
Principal Investigator: Micha S Feinberg, MD         
Assaf Harofeh Medical Center Recruiting
Zrifin, Israel
Contact: Marina Leitman, MD       marina.leitman@gmail.com   
Principal Investigator: Marina Leitman, MD         
Sub-Investigator: Zvi Vered, MD         
Sponsors and Collaborators
Technion, Israel Institute of Technology
Investigators
Principal Investigator: Avinoam Shiran, MD Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology
  More Information

No publications provided

Responsible Party: Avinoam Shiran, Director, Echocardiography, Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology
ClinicalTrials.gov Identifier: NCT01163019     History of Changes
Other Study ID Numbers: 2DS-CP-ED-MSS-IERG
Study First Received: July 12, 2010
Last Updated: April 4, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Technion, Israel Institute of Technology:
Chest pain
acute coronary syndrome
Emergency department
speckle tracking imaging
2D strain
Echocardiography

Additional relevant MeSH terms:
Emergencies
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Chest Pain
Acute Coronary Syndrome
Syndrome
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pain
Signs and Symptoms
Angina Pectoris
Disease

ClinicalTrials.gov processed this record on September 16, 2014