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Real Time 3-Dimensional Stress Echocardiography

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Real time 3-dimensional stress echocardiography
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary Artery Disease, Ischemia, Ultrasound, Ventricular Function, Wall Motion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001886
Brief Title
Real Time 3-Dimensional Stress Echocardiography
Official Title
Real Time 3-Dimensional Stress Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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.
Detailed Description
Stress echocardiography has become a valuable technique for the non-invasive detection of coronary artery disease. Its accuracy has been shown to be superior to that of the exercise electrocardiogram and comparable to that of myocardial perfusion imaging. The adequacy of stress echocardiography with conventional two-dimensional imaging, however, is highly dependent on operator expertise. Further, interpretation of test results is subjective and qualitative, and is based on analysis of wall motion after arbitrary segmentation of the left ventricle. Real time 3-dimensional (RT3D) echocardiography is a new technique that permits the unrestricted assessment of left ventricular wall motion and function in a single cardiac beat without ECG or respiratory gating. We hypothesize that RT3D echocardiography will have similar or greater accuracy for the detection of wall motion abnormalities compared to the conventional two-dimensional examination. We therefore propose to acquire RT3D echocardiographic images in patients with known or suspected coronary artery disease who undergo stress echocardiography. We will correlate these results with findings from coronary angiography and compare the ability of RT3D echocardiography to detect coronary artery disease with that of the conventional two-dimensional exam.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary Artery Disease, Ischemia, Ultrasound, Ventricular Function, Wall Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Real time 3-dimensional stress echocardiography

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1884503
Citation
Armstrong WF. Stress echocardiography for detection of coronary artery disease. Circulation. 1991 Sep;84(3 Suppl):I43-9.
Results Reference
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PubMed Identifier
1673646
Citation
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.
Results Reference
background
PubMed Identifier
8319327
Citation
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.
Results Reference
background

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Real Time 3-Dimensional Stress Echocardiography

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