Comparison of Echocardiographic Techniques in Diagnosis of NCT00001889

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00001889
Other study ID #	990077
Secondary ID	99-H-0077
Status	Completed
Phase	Phase 2
First received	November 3, 1999
Last updated	March 3, 2008
Start date	March 1999
Est. completion date	March 2001

Study information
Verified date	February 2000
Source	National Institutes of Health Clinical Center (CC)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status	Completed
Enrollment	150
Est. completion date	March 2001
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	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 Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Myocardial contrast echocardiography

• Stress echocardiography with dobutamine

Locations
Country	Name	City	State
United States	National Heart, Lung and Blood Institute (NHLBI)	Bethesda	Maryland

Sponsors *(1)*
Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,

References & Publications (3)

Armstrong WF. Stress echocardiography for detection of coronary artery disease. Circulation. 1991 Sep;84(3 Suppl):I43-9. — View Citation

Lumley P, Broadley KJ, Levy GP. Analysis of the inotropic: chronotropic selectivity of dobutamine and dopamine in anaethetised dogs and guinea-pig isolated atria. Cardiovasc Res. 1977 Jan;11(1):17-25. — View Citation

Pellikka PA. Stress echocardiography in the evaluation of chest pain and accuracy in the diagnosis of coronary artery disease. Prog Cardiovasc Dis. 1997 May-Jun;39(6):523-32. Review. — View Citation

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Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

Study information