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

STEMI Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02014701
• Other study ID #: NSTEMI Optison Study
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2013
• Last updated: December 12, 2013
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: December 2013
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 31 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• STEMI

Intervention

Procedure:
• Echocardiogram
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.

Locations

Country	Name	City	State
United States	Cedars-Sinail Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lønnebakken 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath.	No
Secondary	Myocardial Segment Determination	The determination of the number of assessable myocardial segments and the number of assessable abnormal myocardial segments.	Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath.	No