NCT01125072

Brief Summary

Chest pain is one of the most common complaints that brings a patient to the emergency department (ED). The differential diagnosis of chest pain is broad and includes cardiac as well as non-cardiac diseases. One of the initial goals in the ED evaluation of a patient presenting with chest pain is to rapidly and accurately diagnose the presence or absence of acute coronary syndrome. The diagnostic accuracy of the initial routine evaluation is often limited and results in frequent admissions for patients presenting with chest pain for further diagnostic testing. Echocardiography has a high sensitivity and specificity for the diagnosis of acute myocardial infarction. Tissue Doppler imaging with strain and strain rate (SR) measurement is a new echocardiographic technique, which enables accurate assessment of regional left ventricular systolic and diastolic function. Prior studies have shown that abnormal strain and SR are highly sensitive markers of ischemia. Acute ischemia induces early systolic thinning and a delay in the onset of systolic thickening, a progressive decrease in the rate and degree of maximal systolic thickening, and an abnormal ischemia-related thickening which occurs after aortic valve closure. A major obstacle to the routine use of echocardiography in the ED is the need for portable studies, using heavy, bulky portable echo machines. There are currently available portable hand-held echo machines (GE-Vivid I) that produce high quality images and offer an opportunity to incorporate echocardiography into routine practice in the ED. This study will use of early, portable echocardiography, with detailed assessment of wall motion and left ventricular function by strain and strain rate measurements, for the evaluation of chest pain in the ED. It is hypothesized that an early with detailed left ventricular function assessment will be highly sensitive and specific for the diagnosis of myocardial ischemia, and will enable rapid triage of patients who present to the ED with chest pain.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

12.4 years

First QC Date

May 14, 2010

Last Update Submit

November 8, 2017

Conditions

Keywords

chest painechocardiographystrain imaging

Study Arms (1)

entire cohort

patients presenting to the emergency department with chest pain and being admitted to rule out acute coronary syndrome

Other: Echocardiography with strain analysis

Interventions

Clinical routine echocardiogram with additional off line strain analysis

entire cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting to the emergency department with chest pain and are admitted to rule out acute coronary syndrome

You may qualify if:

  • Age 18 or older
  • Chief complaint on presentation to ED: chest pain
  • Differential diagnosis includes acute coronary syndrome as determined by the Emergency physician or admitting attending.
  • Admission to the hospital required for further cardiac work up.

You may not qualify if:

  • Obvious noncardiac cause of the chest pain
  • Patient requires urgent intervention before echo can be obtained
  • Failure to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU School of Medicine, Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gila Perk, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2010

First Posted

May 18, 2010

Study Start

June 1, 2005

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations