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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Swaminatha Gurudevan, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02014701
First received: November 25, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
STEMI
Procedure: Echocardiogram

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Accuracy of determination of the infarct related artery as compared to the findings from clinically indicated coronary angiography [ Time Frame: Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline: Immediately following resting echocardiogram at time of index STEMI and prior to cardiac cath. ] [ Designated as safety issue: No ]
    The determination of the number of assessable myocardial segments and the number of assessable abnormal myocardial segments.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Echocardiogram
  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.

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.

  Eligibility

Ages Eligible for Study:   31 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014701

Locations
United States, California
Cedars-Sinail Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Swaminatha Gurudevan, MD    310-423-3846    Swaminatha.Gurudevan@cshs.org   
Contact: Tracey S Early, BS, MA    310-423-1231    tracey.early@cshs.org   
Principal Investigator: Swaminatha Gurudevan, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
  More Information

Publications:
Responsible Party: Swaminatha Gurudevan, MD, Non-invasive Cardiologist/Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02014701     History of Changes
Other Study ID Numbers: NSTEMI Optison Study
Study First Received: November 25, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cedars-Sinai Medical Center:
echocardiogram
regional wall motion abnormalities
myocardial contrast

ClinicalTrials.gov processed this record on October 19, 2014