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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Lantheus Medical Imaging
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00539045
First received: October 2, 2007
Last updated: September 24, 2010
Last verified: September 2010
  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
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment: 250
Study Start Date: March 2007
Estimated Study Completion Date: March 2012
Groups/Cohorts
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.

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
Study Population

Cross-sectional population of subjects enrolled following ST-elevation myocardial infarction.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539045

Contacts
Contact: Jonathan W Weinsaft, MD 212-746-2437 jww2001@med.cornell.edu

Locations
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Principal Investigator: Jonathan W Weinsaft, MD         
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
  More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
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 April 17, 2014