Real Time 3-Dimensional Stress Echocardiography

NCT00001886 | Completed Phase 2

• 2 other identifiers: 99007499-H-0074
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Disease

Keywords

Coronary Artery Disease; Ischemia; Ultrasound; Ventricular Function; Wall Motion

Interventions

Real time 3-dimensional stress echocardiography PROCEDURE

Eligibility Criteria

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

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.

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)

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

  PMID: 1884503 BACKGROUND

• Sawada SG, Segar DS, Ryan T, Brown SE, Dohan AM, Williams R, Fineberg NS, Armstrong WF, Feigenbaum H. Echocardiographic detection of coronary artery disease during dobutamine infusion. Circulation. 1991 May;83(5):1605-14. doi: 10.1161/01.cir.83.5.1605.

  PMID: 1673646 BACKGROUND

• Mertes H, Sawada SG, Ryan T, Segar DS, Kovacs R, Foltz J, Feigenbaum H. Symptoms, adverse effects, and complications associated with dobutamine stress echocardiography. Experience in 1118 patients. Circulation. 1993 Jul;88(1):15-9. doi: 10.1161/01.cir.88.1.15.

  PMID: 8319327 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Ischemia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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)