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Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain

Primary Purpose

Chest Pain, Angina, Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress Echocardiography
Coronary CT Angiography
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring stress echocardiography, coronary ct angiography

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Montefiore Medical Center - Weiler / Einstein Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Initial Stress Echocardiography

Initial Coronary CT Angiography

Arm Description

Outcomes

Primary Outcome Measures

Hospital admission

Secondary Outcome Measures

Emergency Department length of stay
Hospital length of stay
Estimated cost of initial care
Repeat visits to the Emergency Department
Death
Non-fatal myocardial infarction

Full Information

First Posted
June 15, 2011
Last Updated
October 9, 2018
Sponsor
Montefiore Medical Center
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT01384448
Brief Title
Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain
Official Title
A Randomized Trial Comparing Coronary CT Angiography and Stress Echocardiography for Evaluation of Low-to-Intermediate Risk Emergency Department Chest Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Angina, Angina Pectoris, Coronary Artery Disease
Keywords
stress echocardiography, coronary ct angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial Stress Echocardiography
Arm Type
Experimental
Arm Title
Initial Coronary CT Angiography
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Stress Echocardiography
Other Intervention Name(s)
stress echo, treadmill stress echocardiography, treadmill stress echo, exercise stress echocardiography, exercise stress echo, dobutamine stress echocardiography, dobutamine stress echo, ESE, TSE, DSE, SE
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Coronary CT Angiography
Other Intervention Name(s)
Cardiac CT, Cardiac CTA, Coronary CT, Coronary CTA, Coronary Artery CT, Coronary Artery CTA, CT Angiography of the Coronary Arteries, Computed Tomography Angiography of the Coronary Arteries, CTA, CCT, CCTA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital admission
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Emergency Department length of stay
Time Frame
30 days
Title
Hospital length of stay
Time Frame
30 days
Title
Estimated cost of initial care
Time Frame
30 days
Title
Repeat visits to the Emergency Department
Time Frame
30 days and 1 year
Title
Death
Time Frame
30 days and 1 year
Title
Non-fatal myocardial infarction
Time Frame
30 days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Levsky, MD, PhD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center - Weiler / Einstein Division
City
Bronx
State/Province
New York
ZIP/Postal Code
10462
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24372760
Citation
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.
Results Reference
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PubMed Identifier
29909113
Citation
Levsky 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.
Results Reference
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Stress Echocardiography and Heart Computed Tomography (CT) Scan in Emergency Department Patients With Chest Pain

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