Chest PainNCT01384448
Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain
A study testing Stress Echocardiography and Coronary CT Angiography in people with Chest Pain and Angina, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether stress echocardiography or computed tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to select appropriate candidates for hospitalization and further work-up. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chest Pain, Angina, Angina Pectoris
- What is being tested?
- Stress Echocardiography and Coronary CT Angiography
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2017
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presentation to the Emergency Department with chest pain
- Low-to-intermediate risk of coronary disease per Diamond-Forrester criteria
- Free of known coronary artery disease
Who cannot join
- Inability to undergo both stress echo or coronary CT for any reason
- Contraindication to intravenous iodinated contrast
- Dysrhythmia precluding EKG gating
- Heart rate greater than 60 with contraindication to beta blockers
- Administration of beta blockers within the last 12 hours
- Known severe cardiac valvular disease or pulmonary hypertension
- Stress echocardiography, coronary CT or catheterization within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center - Weiler / Einstein Division
The Bronx, New York, 10462
About this study
Official title: A Randomized Trial Comparing Coronary CT Angiography and Stress Echocardiography for Evaluation of Low-to-Intermediate Risk Emergency Department Chest Pain Patients
The purpose of this study is to determine whether stress echocardiography or computed tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to select appropriate candidates for hospitalization and further work-up.
- Conditions
- Chest Pain, Angina, Angina Pectoris, Coronary Artery Disease
- Being tested
- Stress Echocardiography, Coronary CT Angiography
- Keywords
- stress echocardiography, coronary ct angiography
- Medical subject headings
- Chest Pain, Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress EchocardiographyProcedure or surgery
Also called stress echo, treadmill stress echocardiography, treadmill stress echo, exercise stress echocardiography
Stress echocardiography will be performed once. Treadmill stress is default. Patients that cannot exercise will receive dobutamine stress with or without atropine. Definity intravenous contrast will be given when needed.
Coronary CT AngiographyProcedure or surgery
Also called Cardiac CT, Cardiac CTA, Coronary CT, Coronary CTA
64-detector, resting EKG-gated coronary CT angiography will be performed once. Patients with elevated heart rates will be given oral and/or intravenous metoprolol. Prospective gating with reduced tube current will be default. Retrospective gating with tube current modulation will be used in patients with higher heart rates.
| Study group | Role | What they receive |
|---|---|---|
| Initial Stress Echocardiography | Experimental | Not described Receives: Procedure: Stress Echocardiography |
| Initial Coronary CT Angiography | Experimental | Not described Receives: Procedure: Coronary CT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission
Measured: 30 days
Secondary outcomes (6)
Emergency Department length of stay
Measured: 30 days
Hospital length of stay
Measured: 30 days
Estimated cost of initial care
Measured: 30 days
Repeat visits to the Emergency Department
Measured: 30 days and 1 year
Death
Measured: 30 days and 1 year
Non-fatal myocardial infarction
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jeffrey Levsky, Montefiore Medical Center
- Investigators
- Jeffrey M Levsky, MD, PhD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384448
- Sponsor's protocol ID
- MMC-11-03-107
- Other IDs
- 11SDG7380006
- Status last verified
- Mar 2017
- First submitted
- 15 Jun 2011
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levsky JM, Haramati LB, Taub CC, Spevack DM, Menegus MA, Travin MI, Vega S, Lerer R, Brown-Manhertz D, Hirschhorn E, Tobin JN, Garcia MJ. Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain. Echocardiography. 2014 Jul;31(6):744-50. doi: 10.1111/echo.12464. Epub 2013 Dec 23.
PubMed 24372760Levsky JM, Haramati LB, Spevack DM, Menegus MA, Chen T, Mizrachi S, Brown-Manhertz D, Selesny S, Lerer R, White DJ, Tobin JN, Taub CC, Garcia MJ. Coronary Computed Tomography Angiography Versus Stress Echocardiography in Acute Chest Pain: A Randomized Controlled Trial. JACC Cardiovasc Imaging. 2018 Sep;11(9):1288-1297. doi: 10.1016/j.jcmg.2018.03.024. Epub 2018 Jun 13.
PubMed 29909113
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Coronary CT Angiography and Stress Echocardiography for Evaluation of Low-to-Intermediate Risk Emergency Department Chest Pain Patients
- ClinicalTrials.gov ID
- NCT01384448
- Acronym / sponsor ID
- MMC-11-03-107
- Conditions
- Chest Pain, Angina, Angina Pectoris, Coronary Artery Disease
- Keywords
- stress echocardiography, coronary ct angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Aug 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Jun 2011 (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.
The purpose of this study is to determine whether stress echocardiography or computed tomography (CT) of the heart is better at diagnosing emergency room chest pain patients to select appropriate candidates for hospitalization and further work-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Stress Echocardiography | Experimental | Procedure: Stress Echocardiography |
| Initial Coronary CT Angiography | Experimental | Procedure: Coronary CT Angiography |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presentation to the Emergency Department with chest pain
- Low-to-intermediate risk of coronary disease per Diamond-Forrester criteria
- Free of known coronary artery disease
Key exclusion criteria (7 listed)
- Inability to undergo both stress echo or coronary CT for any reason
- Contraindication to intravenous iodinated contrast
- Dysrhythmia precluding EKG gating
- Heart rate greater than 60 with contraindication to beta blockers
- Administration of beta blockers within the last 12 hours
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 |
|---|---|---|
| Stress EchocardiographyAlso: stress echo, treadmill stress echocardiography, treadmill stress echo, exercise stress echocardiographyStress echocardiography will be performed once. Treadmill stress is default. Patients that cannot exercise will receive dobutamine stress with or without atropine. Definity intravenous contrast will be given when needed. | Procedure or surgery | Initial Stress Echocardiography |
| Coronary CT AngiographyAlso: Cardiac CT, Cardiac CTA, Coronary CT, Coronary CTA64-detector, resting EKG-gated coronary CT angiography will be performed once. Patients with elevated heart rates will be given oral and/or intravenous metoprolol. Prospective gating with reduced tube current will be default. Retrospective gating with tube current modulation will be used in patients with higher heart rates. | Procedure or surgery | Initial Coronary CT Angiography |
Primary outcome
Hospital admission
Time frame: 30 days
6 secondary outcomes
Emergency Department length of stay
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
Estimated cost of initial care
Time frame: 30 days
Repeat visits to the Emergency Department
Time frame: 30 days and 1 year
Death
Time frame: 30 days and 1 year
Non-fatal myocardial infarction
Time frame: 30 days and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 24372760Levsky JM, Haramati LB, Taub CC, Spevack DM, Menegus MA, Travin MI, Vega S, Lerer R, Brown-Manhertz D, Hirschhorn E, Tobin JN, Garcia MJ. Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain. Echocardiography. 2014 Jul;31(6):744-50. doi: 10.1111/echo.12464. Epub 2013 Dec 23.
- Background: PubMed 29909113Levsky JM, Haramati LB, Spevack DM, Menegus MA, Chen T, Mizrachi S, Brown-Manhertz D, Selesny S, Lerer R, White DJ, Tobin JN, Taub CC, Garcia MJ. Coronary Computed Tomography Angiography Versus Stress Echocardiography in Acute Chest Pain: A Randomized Controlled Trial. JACC Cardiovasc Imaging. 2018 Sep;11(9):1288-1297. doi: 10.1016/j.jcmg.2018.03.024. Epub 2018 Jun 13.
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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.
Jeffrey M Levsky, MD, PhD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Echocardiography and Coronary CT Angiography in people with Chest Pain and Angina, run by Montefiore Medical Center 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 11 Oct 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Hospital admission (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384448, which also lists 2 linked publications.
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 11 Oct 2018.