Diagnostic Utility of Contrast Echocardiography for Detection of LV Thrombi Post ST Elevation Myocardial Infarction
Recruitment status was Recruiting
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Purpose
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 |
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Thrombus Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Diagnostic Utility of Contrast Echocardiography for Detection of Left Ventricular Thrombi Post ST Elevation Myocardial Infarction |
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2012 |
| Groups/Cohorts |
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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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Cross-sectional population of subjects enrolled following ST-elevation myocardial infarction.
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| Contact: Jonathan W Weinsaft, MD | 212-746-2437 | jww2001@med.cornell.edu |
| United States, New York | |
| Weill Medical College of Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Principal Investigator: Jonathan W Weinsaft, MD | |
| Principal Investigator: | Jonathan W Weinsaft, MD | Weill Medical College of Cornell University |
| Study Chair: | Richard B Devereux, MD | Weill Medical College of Cornell University |
More Information
No publications provided
| Responsible Party: | Jonathan Weinsaft, M.D., Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00539045 History of Changes |
| Other Study ID Numbers: | 0610008782 |
| Study First Received: | October 2, 2007 |
| Last Updated: | September 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
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myocardial infarction, thrombus |
Additional relevant MeSH terms:
|
Myocardial Infarction Infarction Thrombosis Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis |
ClinicalTrials.gov processed this record on May 22, 2013