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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01163019
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Avinoam Shiran, Technion, Israel Institute of Technology

Tracking Information
First Submitted Date July 12, 2010
First Posted Date July 15, 2010
Last Update Posted Date October 28, 2014
Study Start Date September 2010
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2010)
  • Acute coronary syndrome [ Time Frame: 1 week ]
  • Significant coronary artery disease. [ Time Frame: 1 week ]
Original Primary Outcome Measures
 (submitted: July 14, 2010)
Acute coronary syndrome or significant coronary artery disease. [ Time Frame: 1 week ]
Change History Complete list of historical versions of study NCT01163019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 14, 2010)
Major adverse cardiac events (MACE - death, MI or revascularization) [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room
Official Title Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients presenting to the emergency department with a chief complaint of chest pain
Condition
  • Chest Pain
  • Coronary Artery Disease
  • Acute Coronary Syndrome
Intervention Not Provided
Study 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 27, 2014)
700
Original Estimated Enrollment
 (submitted: July 14, 2010)
1200
Actual Study Completion Date September 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01163019
Other Study ID Numbers 2DS-CP-ED-MSS-IERG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Avinoam Shiran, Technion, Israel Institute of Technology
Study Sponsor Technion, Israel Institute of Technology
Collaborators Not Provided
Investigators
Principal Investigator: Avinoam Shiran, MD Lady Davis Carmel Medical Center, Technion, Israel Institute of Technology
PRS Account Technion, Israel Institute of Technology
Verification Date October 2014