Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease

March 3, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Comparison of Myocardial Contrast Echo With Dobutamine Echo in Diagnosis of Coronary Artery Disease

This study is designed to compare two different echocardiographic techniques in the evaluation of heart disease (coronary artery disease). Both tests called Myocardial Contrast Echocardiography with Pharmacologic Stress and Stress Echocardiography with Dobutamine, are performed using a standard echocardiographic machine.

Myocardial Contrast Echocardiography (MCE) does not use radioactivity. It uses sound waves like standard echocardiography. However, with MCE patients receive an injection of a "contrast agent" directly into the blood stream through a vein. The contrast agent, called Optison, is made of tiny microbubbles smaller than red blood cells. The echocardiogram can detect these microbubbles in the small blood vessels of the heart muscle and allow researchers to find areas of the heart receiving less blood flow than others. It is important to observe the heart during exercise because there are changes in blood flow. Since MCE cannot be performed when the patient is exercising, researchers give medication (adenosine) that stimulates the heart and creates a situation similar to exercise.

Stress Echocardiography with Dobutamine does not use radioactivity. It uses sound waves like standard echocardiography. During this echocardiogram patients receive doses of a medication called dobutamine that stimulates the heart to beat stronger and faster.

The purpose of this study is to evaluate the accuracy of MCE compared to stress echocardiography at detecting coronary artery disease (CAD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stress echocardiography has become a valuable technique for the non-invasive detection of coronary artery disease (CAD). Its accuracy has been shown to be superior to that of the exercise electrocardiogram and comparable to that of myocardial perfusion imaging. Myocardial contrast echocardiography (MCE) offers the potential to evaluate tissue perfusion at the level where oxygen transfer to the myocytes occurs. MCE can, therefore, provide information regarding the functional status of the myocardial microvasculature and presence of blood flow disparity. The purpose of this study is to evaluate the accuracy of MCE compared to stress echocardiography. We will correlate these results with findings from coronary angiography and compare the ability of those techniques to detect CAD.

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

  • United States
    • 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 with known or suspected coronary artery disease.

Adults 18 years of age or older.

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

No unstable angina patients.

No recent myocardial infarction patients (less than 1 month).

No frequent ectopy which precludes adequate image acquisition.

No history of asthma or chronic obstructive pulmonary disease.

No patients receiving aminophylline, theophylline or dipyridamole.

No presence of second and third degree heart block without pacemaker.

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

No hypotension: basal sitting systolic arterial pressure less than 100 mm Hg confirmed 30 minutes later.

No sinus tachycardia greater than or equal to 100 beats per min.

No atrial fibrillation.

No 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.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

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

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990077
  • 99-H-0077

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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