- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001886
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Armstrong WF. Stress echocardiography for detection of coronary artery disease. Circulation. 1991 Sep;84(3 Suppl):I43-9.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 990074
- 99-H-0074
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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