Diagnostic Utility of Contrast Echocardiography for Detection of LV Thrombi Post ST Elevation Myocardial Infarction

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00539045

Collaborator

Lantheus Medical Imaging (Industry)

250

Enrollment

Location

94.1

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a cross-sectional study of post myocardial infarction patients which is designed to determine the prevalence of left ventricular thrombi (blood clots) using non-contrast echocardiography and to compare this with the prevalence of left ventricular thrombi using contrast echocardiography. Secondary aims of this study are (1) to identify clinical and imaging correlates of left ventricular thrombi, and (2) to compare quantitative measurements of left ventricular chamber size, function, and myocardial mass using contrast and non-contrast echocardiography.

Condition or Disease	Intervention/Treatment	Phase
Thrombus Myocardial Infarction

Detailed Description

People that experience heart attacks ("myocardial infarctions") are at increased risk for stroke, possibly due to formation of blood clots ("left ventricular thrombi"), which may break loose from the heart and travel to other organs. While echocardiography is a test commonly employed for thrombus detection, prior studies have yielded heterogeneous findings regarding prevalence and predictors. Echocardiographic contrast ("perflutren lipid microspheres") are FDA approved imaging agents that have been shown to improve thrombus detection in selected populations. However, the decision to use contrast is often predicated upon results of non-contrast echocardiography, a diagnostic strategy that hasn't been well studied. This study is designed to test whether echocardiographic contrast improves thrombus detection following myocardial infarction. Participants will undergo non-contrast and contrast echocardiography. These will be compared for identification of thrombi and assessment of cardiac size and function. Clinical features and results of other diagnostic tests will also be reviewed in order to study whether these predict thrombus risk. Participants will be contacted at regular intervals by study investigators to determine whether thrombi identified by contrast or non-contrast echocardiography predict risk for stroke or cardiac events. Findings from this study may improve detection of thrombi, thereby improving treatment for patients following myocardial infarction.

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Diagnostic Utility of Contrast Echocardiography for Detection of Left Ventricular Thrombi Post ST Elevation Myocardial Infarction

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
A The study population will consist of patients who are admitted to The New York Presbyterian Hospital-Weill Medical College of Cornell University (NYP-WMC) with ST elevation myocardial infarctions (STEMI). STEMI will be established based on standard clinical and ECG criteria.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

all patients who are admitted to The New York Presbyterian Hospital-Weill Medical College of Cornell University (NYP-WMC) with ST elevation myocardial infarctions

Exclusion Criteria:

contraindications to MRI at time of planned imaging (e.g. metallic contra-indication, pacemaker, implantable cardiac defibrillator, cochlear implants, aneurysm clips intolerance of the imaging protocol due to NYHA IV heart failure or CCS class IV angina)
known allergy/contra-indications to gadolinium or echo contrast agents (i.e. known intracardiac shunt, severe reactive airway disease)
known pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Medical College of Cornell University	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University
Lantheus Medical Imaging

Investigators

Principal Investigator: Jonathan W Weinsaft, MD, Weill Medical College of Cornell University
Study Chair: Richard B Devereux, MD, Weill Medical College of Cornell University