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

Not Applicable

• Conditions: STEMI
• Interventions: Procedure: Echocardiogram

• Registration Number: NCT02014701
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-11-25
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-18
• Last Update Posted: 2013-12-18
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Echocardiogram	Echocardiogram	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of determination of the infarct related artery as compared to the findings from clinically indicated coronary angiography	Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath.	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

Name	Time	Method
Myocardial Segment Determination	Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath.	The determination of the number of assessable myocardial segments and the number of assessable abnormal myocardial segments.

Trial Locations

Locations (1)

Cedars-Sinail Medical Center; 🇺🇸 Los Angeles, California, United States