Chest PainNCT01125072
Use of Echocardiography in the Evaluation of Chest Pain in the Emergency Department
An observational study of Chest Pain, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- Echocardiography with strain analysis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the emergency department with chest pain and are admitted to rule out acute coronary syndrome
Who may be able to join
- 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.
Who cannot join
- Obvious noncardiac cause of the chest pain
- Patient requires urgent intervention before echo can be obtained
- Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine, Langone Medical Center
New York, New York, 10016
About this study
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.
- Conditions
- Chest Pain
- Being tested
- Echocardiography with strain analysis
- Keywords
- chest pain, echocardiography, strain imaging
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography with strain analysisOther
Clinical routine echocardiogram with additional off line strain analysis
| Study group | Role | What they receive |
|---|---|---|
| entire cohort | patients presenting to the emergency department with chest pain and being admitted to rule out acute coronary syndrome Receives: Other: Echocardiography with strain analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJun 2005
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: PI no longer with institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gila Perk, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125072
- Sponsor's protocol ID
- 05-264
- Status last verified
- Nov 2017
- First submitted
- 14 May 2010
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Echocardiography in the Evaluation of Chest Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT01125072
- Acronym / sponsor ID
- 05-264
- Conditions
- Chest Pain
- Keywords
- chest pain, echocardiography, strain imaging
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI no longer with institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| entire cohort | – | Other: Echocardiography with strain analysispatients presenting to the emergency department with chest pain and being admitted to rule out acute coronary syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the emergency department with chest pain and are admitted to rule out acute coronary syndrome
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Obvious noncardiac cause of the chest pain
- Patient requires urgent intervention before echo can be obtained
- Failure to obtain informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography with strain analysisClinical routine echocardiogram with additional off line strain analysis | Other | entire cohort |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gila Perk, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.