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Myocardial Contrast Echocardiography for the Assessment of the Infarct Related Artery & Risk Area in Patients w/ NSTEMI.

Primary Purpose

STEMI

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echocardiogram
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for STEMI focused on measuring echocardiogram, regional wall motion abnormalities, myocardial contrast

Eligibility Criteria

31 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI

Exclusion Criteria:

Inability to undergo a contrast echocardiogram Unwillingness to consent to a contrast echocardiogram

Sites / Locations

  • Cedars-Sinail Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Echocardiogram

Arm Description

Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI will be selected for participation in the study. The patients will undergo a clinically indicated resting non-contrast echocardiogram to assess LV function and regional wall motion. They will then undergo contrast echocardiography with bolus injection of Optison™ contrast to reassess LV ejection fraction, improve LV opacification and assess regional wall motion abnormalities. Finally, they will be given a continuous infusion of Optison™ and will have assessment of myocardial perfusion of each of the 17 myocardial segments using low mechanical index continuous imaging of the myocardium and blood pool.

Outcomes

Primary Outcome Measures

Accuracy of determination of the infarct related artery as compared to the findings from clinically indicated coronary angiography
Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI will be selected for participation in the study. The patients will undergo a clinically indicated resting non-contrast echocardiogram to assess LV function and regional wall motion. Immediately following, they will then undergo contrast echocardiography with bolus injection of Optison™ contrast to reassess LV ejection fraction, improve LV opacification and assess regional wall motion abnormalities. Finally, they will be given a continuous infusion of Optison™ and will have assessment of myocardial perfusion of each of the 17 myocardial segments using low mechanical index continuous imaging of the myocardium and blood pool.

Secondary Outcome Measures

Myocardial Segment Determination
The determination of the number of assessable myocardial segments and the number of assessable abnormal myocardial segments.

Full Information

First Posted
November 25, 2013
Last Updated
December 12, 2013
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02014701
Brief Title
Myocardial Contrast Echocardiography for the Assessment of the Infarct Related Artery & Risk Area in Patients w/ NSTEMI.
Official Title
Incremental Utility of Myocardial Contrast Echocardiography for the Assessment of the Infarct Related Artery and Risk Area in Patients With Non-ST Segment Elevation Myocardial Infarction.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study will be to assess the incremental benefit of myocardial contrast echocardiography for the assessment of regional wall motion abnormalities and infarct-related artery in patients presenting with their first NSTEMI.
Detailed Description
Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI will be selected for participation in the study. The patients will undergo a clinically indicated resting non-contrast echocardiogram to assess LV function and regional wall motion. They will then undergo contrast echocardiography with bolus injection of Optison™ contrast to reassess LV ejection fraction, improve LV opacification and assess regional wall motion abnormalities. Finally, they will be given a continuous infusion of Optison™ and will have assessment of myocardial perfusion of each of the 17 myocardial segments using low mechanical index continuous imaging of the myocardium and blood pool. Two expert echocardiographers will be asked to review in a blinded fashion the non-contrast echocardiogram, interpret the ejection fraction, and assess regional wall motion abnormalities in each of the 17 myocardial segments. They will then be asked to predict the infarct-related artery (either LAD, LCx, or RCA). A proposed sample size of 100 patients presenting to Cedars-Sinai Medical Center with their first NSTEMI will be studied. Based on hospital volume, approximately 4-5 NSTEMI patients present to Cedars-Sinai on a weekly basis, of which at least 2 will be eligible per week. Based on this trend, we feel we can achieve the necessary sample size within 12 months. Inclusion criteria will be patients aged 31-90 presenting with World Health Organization diagnosis of non-ST segment elevation myocardial infarction, which encompass 2 out of the following 3 criteria: a clinical history of chest pain unrelieved by nitroglycerin, ECG evidence of cardiac ischemia (ST segment depression or T wave inversion), and enzymatic evidence of myocardial infarction (elevation of TnI or CKMB). Patients should be clinically eligible for coronary angiography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI
Keywords
echocardiogram, regional wall motion abnormalities, myocardial contrast

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Echocardiogram
Arm Type
Other
Arm Description
Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI will be selected for participation in the study. The patients will undergo a clinically indicated resting non-contrast echocardiogram to assess LV function and regional wall motion. They will then undergo contrast echocardiography with bolus injection of Optison™ contrast to reassess LV ejection fraction, improve LV opacification and assess regional wall motion abnormalities. Finally, they will be given a continuous infusion of Optison™ and will have assessment of myocardial perfusion of each of the 17 myocardial segments using low mechanical index continuous imaging of the myocardium and blood pool.
Intervention Type
Procedure
Intervention Name(s)
Echocardiogram
Intervention Description
Contrast echocardiography with Optison for assessment of regional wall motion. This will be performed immediately following the resting echocardiogram by a sonographer specifically trained in myocardial contrast echocardiography. Contrast echocardiogram with Optison for assessment of myocardial perfusion. This will be performed using a continuous infusion of Optison using low mechanical index power-modulation imaging of the myocardium and blood pool. Myocardial perfusion will be assessed offline using video intensity analysis software.
Primary Outcome Measure Information:
Title
Accuracy of determination of the infarct related artery as compared to the findings from clinically indicated coronary angiography
Description
Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI will be selected for participation in the study. The patients will undergo a clinically indicated resting non-contrast echocardiogram to assess LV function and regional wall motion. Immediately following, they will then undergo contrast echocardiography with bolus injection of Optison™ contrast to reassess LV ejection fraction, improve LV opacification and assess regional wall motion abnormalities. Finally, they will be given a continuous infusion of Optison™ and will have assessment of myocardial perfusion of each of the 17 myocardial segments using low mechanical index continuous imaging of the myocardium and blood pool.
Time Frame
Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath.
Secondary Outcome Measure Information:
Title
Myocardial Segment Determination
Description
The determination of the number of assessable myocardial segments and the number of assessable abnormal myocardial segments.
Time Frame
Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting with NSTEMI who are scheduled to undergo elective cardiac catheterization and coronary angiography with primary PCI Exclusion Criteria: Inability to undergo a contrast echocardiogram Unwillingness to consent to a contrast echocardiogram
Facility Information:
Facility Name
Cedars-Sinail Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swaminatha Gurudevan, MD
Phone
310-423-3846
Email
Swaminatha.Gurudevan@cshs.org
First Name & Middle Initial & Last Name & Degree
Tracey S Early, BS, MA
Phone
310-423-1231
Email
tracey.early@cshs.org
First Name & Middle Initial & Last Name & Degree
Swaminatha Gurudevan, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
11897214
Citation
Yong Y, Wu D, Fernandes V, Kopelen HA, Shimoni S, Nagueh SF, Callahan JD, Bruns DE, Shaw LJ, Quinones MA, Zoghbi WA. Diagnostic accuracy and cost-effectiveness of contrast echocardiography on evaluation of cardiac function in technically very difficult patients in the intensive care unit. Am J Cardiol. 2002 Mar 15;89(6):711-8. doi: 10.1016/s0002-9149(01)02344-x.
Results Reference
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PubMed Identifier
21349478
Citation
Lonnebakken MT, Staal EM, Nordrehaug JE, Gerdts E. Usefulness of contrast echocardiography for predicting the severity of angiographic coronary disease in non-ST-elevation myocardial infarction. Am J Cardiol. 2011 May 1;107(9):1262-7. doi: 10.1016/j.amjcard.2010.12.034. Epub 2011 Feb 23.
Results Reference
background
PubMed Identifier
20418056
Citation
Wei K, Peters D, Belcik T, Kalvaitis S, Womak L, Rinkevich D, Tong KL, Horton K, Kaul S. A predictive instrument using contrast echocardiography in patients presenting to the emergency department with chest pain and without ST-segment elevation. J Am Soc Echocardiogr. 2010 Jun;23(6):636-42. doi: 10.1016/j.echo.2010.03.013. Epub 2010 Apr 24.
Results Reference
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Myocardial Contrast Echocardiography for the Assessment of the Infarct Related Artery & Risk Area in Patients w/ NSTEMI.

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