Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram

June 21, 2010 updated by: Gundersen Lutheran Medical Foundation

Detection of Left Atrial Appendage Thrombus in Patients Referred For Cardioversion: Comparative Analysis of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram

The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.

Study Overview

Status

Unknown

Conditions

Detailed Description

The identification of left atrial appendage (LAA) thrombus prior to cardioversion for patients with atrial fibrillation is crucial. LAA thrombus can be a frequent cause of cerebral stroke or peripheral embolism post cardioversion, and anticoagulation therapy is required in these instances to prevent cerebral events and avoid embolization. To date, TEE has been considered the clinical reference in detection of LAA thrombi with high diagnostic accuracy. However, diagnosis and size estimation of LAA thrombi remains challenging due to the complex anatomy of the LAA, and transesophageal echocardiography (TEE) is considered a semi-invasive procedure. To date, there have been few comparative studies involving TEE and cardiac magnetic resonance (CMR) imaging, and the results have been conflicting. With newer CMR Imaging techniques now available, we hypothesize that comparable results will be achieved in detecting LAA thrombus in subjects using a less invasive procedure.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Health System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raju G Ailiani, MD

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

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study cases will consist of subjects referred for TEE prior to cardioversion who are found to have LAA thrombus present. Control subjects will be patients referred for TEE with chronic atrial fibrillation that will not be undergoing cardioversion. All subjects will be patients from our facility, Gundersen Lutheran Health System, La Crosse, WI.

Description

Inclusion Criteria:

  • atrial fibrillation

Exclusion Criteria:

  • ICDs
  • pacemakers
  • intracranial clips
  • intracranial stimulator devices
  • insulin pumps
  • intra ocular metal foreign bodies
  • cochlear implants
  • LAA amputation as part of CABG and/or valve surgery
  • GFR < 60 mL/min

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
1/Cases
Subjects whom had cardioversion aborted due to LAA thrombus or suspicion of LAA thrombus on TEE.
2/Controls
Subjects with underlying atrial fibrillation undergoing elective TEE as clinically indicated for any reason.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy values for CMR Imaging for detection of LAA thrombus. (sensitivity, specificity, negative predictive value, and positive predictive value)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Gundersen Lutheran Medical Foundation

Collaborators

Gundersen Lutheran Health System

Investigators

  • Principal Investigator: Raju G Ailiani, MD, Gundersen Lutheran Health System
  • Study Director: Vicki L McHugh, MS, Gundersen Lutheran Medical Foundation

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

June 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (ESTIMATE)

November 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 21, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-07-05-001

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.

Clinical Trials on Left Atrial Appendage Thrombi

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe