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Myocardial Contrast Echocardiography (MCE) to Check for Living and Working Heart Muscle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001891
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

Coronary artery disease (CAD) can cause poor blood flow and supply to the heart muscle. It can result in irreversible damage to the heart muscle and poor function. Before treating patients with heart disease it is important to know how well the heart is functioning. Echocardiography is a diagnostic test that can measure heart function. If part of the heart muscle is not working properly due to previous damage, echocardiography can provide information about how much improvement can be expected after treatment (surgery or angioplasty).

The purpose of this study is to compare the accuracy of myocardial contrast echocardiography (MCE) to dobutamine echocardiography to detect the potential for damaged heart muscle to be treated and function in patients with heart disease.

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.

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. Heart muscle that does not beat stronger after dobutamine is probably dead, usually as a result of a previous heart attack.


Condition Intervention Phase
Coronary Disease Heart Diseases Procedure: Myocardial contrast echocardiography Procedure: Dobutamine echocardiography Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Assessment of Myocardial Viability Utilizing Myocardial Contrast Echocardiography

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: May 1999
Estimated Study Completion Date: March 2001
Detailed Description:
Dobutamine echocardiography has become a valuable technique for the evaluation of myocardial viability in patients with coronary artery disease (CAD) and dysfunctional myocardium because it can accurately predict which myocardial segments will show contractile recovery after successful revascularization. Myocardial contrast echocardiography (MCE) offers the potential to evaluate tissue perfusion at the level where oxygen transfer to the myocytes occurs. MCE, therefore, can provide information regarding the functional status of the myocardial microvasculature which has a close relationship with myocellular integrity. The purpose of this study is to evaluate the accuracy of MCE compared to dobutamine echocardiography to detect myocardial viability in patients with CAD and resting wall motion abnormalities.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients undergoing evaluation for CAD who show at least two myocardial segments with wall motion abnormalities on a baseline echocardiogram will be offered to participate in this study.

Patients will be adults older than 21 years of age.

No pre-menopausal patients who are lactating, are pregnant or potentially pregnant as judged by history, physical examination, ultrasound or urine pregnancy test.

No one with unstable angina.

No subjects with recent myocardial infarction (less than 1 month).

No one with frequent ectopy which precludes adequate imaging acquisition.

No subjects with significant hypertension (systolic blood pressure greater than 170 mm Hg).

No hypotension with basal sitting systolic arterial pressure less than 100 mm HG confirmed 30 minutes later.

No subjects with sinus tachycardia greater than or equal to 100 beats/minute.

No atrial fibrillation.

No inadequate two-dimensional echocardiographic windows.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001891


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001891     History of Changes
Other Study ID Numbers: 990108
99-H-0108
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: March 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
CABG
Hibernation
LV Function
Microbubbles
Revascularization
Coronary Artery Disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents