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

Coronary Artery Disease Clinical Trial

— 2DSPER  

Official title:

Utility of 2D Strain Echocardiography in Triage of Patients With Chest Pain in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163019
• Other study ID #: 2DS-CP-ED-MSS-IERG
• Status: Completed
• Phase: N/A
• First received: July 12, 2010
• Last updated: October 27, 2014
• Start date: September 2010
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Technion, Israel Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Emergencies
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	Ha'Emek Medical Center,	Afula
Israel	Soroka University Medical Center	Beer Sheva
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	Rabin Medical Center	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Chaim Sheba Medical Center	Tel Hashomer
Israel	Assaf Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute coronary syndrome		1 week	No
Primary	Significant coronary artery disease.		1 week	No
Secondary	Major adverse cardiac events (MACE - death, MI or revascularization)		6 months	No