Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography

February 16, 2012 updated by: Lahey Clinic

Patterns Of Left Ventricular Remodeling In Patients With Aortic Stenosis Assessed By Two-Dimensional And Three-Dimensional Echocardiography

This preliminary study will compare the effectiveness of two-dimensional and three-dimensional echocardiographic measurements of wall thickness and left ventricular mass in patients with Aortic Stenosis

Study Overview

Status

Withdrawn

Conditions

Detailed Description

This study will evaluate left ventricular patterns of remodeling and hypertrophy in patients with aortic stenosis, and compare two-dimensional echocardiography measurements (wall thickness) with three-dimensional echocardiography data(left ventricular mass). Along with a second objective to assess Doppler diastolic filling indices associated with the various patterns of left ventricular remodeling.

Previous studies(see reference list) were primarily derived from two-dimensional echo data set(based on wall thickness). Various patterns of left ventricular remodeling have been described in response to increased pressure overload.

Three-dimensional echocardiography is a relatively new technique that is being increasingly used in the Echocardiography Lab in selected patients. This technique holds promise of being more accurate for volume-related measurements than the standard 2-dimensional echocardiography techniques.

Study Type

Observational

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
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic, Inc.

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lahey Clinic patients who have been referred to the echocardiography lab for clinical indications, found to have a aortic stenosis

Description

Inclusion Criteria:

  • Subjects more than 18 yrs of age through 90 yrs of age
  • Both male and female
  • Patients with moderate or severe isolated Aortic Stenosis
  • Patients who have been referred for both two-dimensional and three- dimensional echocardiographies.

Exclusion Criteria:

  • Poor acoustic windows
  • h/o CAD and wall motion abnormality

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate 2-dimensional and 3-dimensional echocardiography for LV patterns of remodeling and hypertrophy
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess doppler diastolic filling indices for patterns of LV remodeling
Time Frame: 1 hour
1 hour

Collaborators and Investigators

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

Sponsor

Lahey Clinic

Collaborators

Tufts Medical Center

Investigators

  • Principal Investigator: Sherif B. Labib, M.D., Lahey Clinic, Inc.

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

September 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-090

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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