Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease

NCT00001889 | Completed Phase 2

• 2 other identifiers: 99007799-H-0077
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Coronary Disease

Keywords

Microbubbles; Myocardial Blood Flow; Myocardial Ischemia; Second Harmonics; Ultrasound; Coronary Artery Disease

Interventions

Myocardial contrast echocardiography PROCEDURE

Stress echocardiography with dobutamine PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1093/cvr/11.1.17.

  PMID: 12867 BACKGROUND

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

  PMID: 1884503 BACKGROUND

• 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. doi: 10.1016/s0033-0620(97)80011-4.

  PMID: 9166363 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Myocardial Ischemia; Coronary Artery Disease

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: March 1, 1999
• Study Completion: March 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-02

Locations

US (1)