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Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Myocardial contrast echocardiography
Stress echocardiography with dobutamine
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 Microbubbles, Myocardial Blood Flow, Myocardial Ischemia, Second Harmonics, Ultrasound, Coronary Artery Disease

Eligibility Criteria

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

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.

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
NCT00001889
Brief Title
Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease
Official Title
Comparison of Myocardial Contrast Echo With Dobutamine Echo in Diagnosis of Coronary Artery Disease
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
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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Microbubbles, Myocardial Blood Flow, Myocardial Ischemia, Second Harmonics, Ultrasound, Coronary Artery Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Myocardial contrast echocardiography
Intervention Type
Procedure
Intervention Name(s)
Stress echocardiography with dobutamine

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
12867
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. doi: 10.1093/cvr/11.1.17.
Results Reference
background
PubMed Identifier
1884503
Citation
Armstrong WF. Stress echocardiography for detection of coronary artery disease. Circulation. 1991 Sep;84(3 Suppl):I43-9.
Results Reference
background
PubMed Identifier
9166363
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. doi: 10.1016/s0033-0620(97)80011-4.
Results Reference
background

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Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease

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