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

February 13, 2018 updated by: Jonathan W. Weinsaft, Weill Medical College of Cornell University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lantheus Medical Imaging

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan W Weinsaft, MD, Weill Medical College of Cornell University
  • Study Chair: Richard B Devereux, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0610008782

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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