Real Time 3-Dimensional Stress Echocardiography

An echocardiogram is an ultrasound technique used to gather information about the heart. Standard echocardiograms create images of the heart in two dimensions, thereby named 2D (two-dimensional) echocardiography. A new technique has been developed allowing images to be taken of the heart in three dimensions (real time 3D echocardiography).

The 3D echocardiogram uses high frequency sound waves to see and record the movement and function of the heart muscle. The echocardiogram is taken by placing an instrument called a transducer against the chest wall over the heart.

In this study patients will undergo a dobutamine stress echocardiogram. Dobutamine is drug that causes the heart to beat stronger and faster, similar to how it acts when exercising. Dobutamine allows researchers to tell if the heart is suffering from a lack of oxygen during exercise or other forms of stress, or if it is permanently damaged.

The purpose of this study is to determine whether stress 3D echocardiography is feasible and accurate in the detection of heart disease (coronary artery disease). Results of the 3D echocardiogram will be compared to results from standard 2D echocardiograms.

Study Overview

Status

Completed

Conditions

Detailed Description

Stress echocardiography has become a valuable technique for the non-invasive detection of coronary artery disease. Its accuracy has been shown to be superior to that of the exercise electrocardiogram and comparable to that of myocardial perfusion imaging. The adequacy of stress echocardiography with conventional two-dimensional imaging, however, is highly dependent on operator expertise. Further, interpretation of test results is subjective and qualitative, and is based on analysis of wall motion after arbitrary segmentation of the left ventricle. Real time 3-dimensional (RT3D) echocardiography is a new technique that permits the unrestricted assessment of left ventricular wall motion and function in a single cardiac beat without ECG or respiratory gating. We hypothesize that RT3D echocardiography will have similar or greater accuracy for the detection of wall motion abnormalities compared to the conventional two-dimensional examination. We therefore propose to acquire RT3D echocardiographic images in patients with known or suspected coronary artery disease who undergo stress echocardiography. We will correlate these results with findings from coronary angiography and compare the ability of RT3D echocardiography to detect coronary artery disease with that of the conventional two-dimensional exam.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

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

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Heart, Lung and Blood Institute (NHLBI)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients older than 18 years of age with known or suspected coronary artery disease who agree to undergo stress echocardiography and have undergone or will undergo coronary angiography within 3 months of the stress echocardiogram.

No pre-menopausal patients who are lactating, are pregnant or potentially pregnant as judged by history, physical examination, ultrasound or urine pregnancy test.

No unstable angina.

No recent myocardial infarction (less than 1 month).

No ventricular ectopy during baseline conditions (i.e., couplets, frequent PVC's [greater than 6/min], early coupling ["R-on-T" phenomenon], ventricular bigeminy) that might potentially predispose the patient for the development of dangerous dysrhythmias during dobutamine infusion.

No congestive heart failure.

No significant hypertension (systolic blood pressure greater than 170 mmHg) or hypotension (systolic blood pressure less than 100 mmHg).

No sinus tachycardia greater than 100 beats/min.

No other acute medical illness.

No atrial fibrillation, or inadequate two-dimensional echocardiographic windows.

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

  • Primary Purpose: Treatment

Collaborators and Investigators

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

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.

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

March 1, 1999

Study Completion

March 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

February 1, 2000

More Information

Terms related to this study

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 Coronary Disease

Clinical Trials on Real time 3-dimensional stress echocardiography

3
Subscribe