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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02014701
Enrollment
100
Registered
2013-12-18
Start date
2012-08-31
Completion date
2014-03-31
Last updated
2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI

Keywords

echocardiogram, regional wall motion abnormalities, myocardial contrast

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.

Interventions

PROCEDUREEchocardiogram

1. 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. 2. 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.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
31 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of determination of the infarct related artery as compared to the findings from clinically indicated coronary angiographyBaseline: 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

MeasureTime frameDescription
Myocardial Segment DeterminationBaseline: 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026