Coronary DiseasePhase 3NCT00001891
Myocardial Contrast Echocardiography (MCE) to Check for Living and Working Heart Muscle
A Phase 3 study testing Myocardial contrast echocardiography and Dobutamine echocardiography in people with Coronary Disease and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease, Heart Diseases
- What is being tested?
- Myocardial contrast echocardiography and Dobutamine echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Mar 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Assessment of Myocardial Viability Utilizing Myocardial Contrast Echocardiography
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.
Read more
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.
Read the 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.
- Conditions
- Coronary Disease, Heart Diseases
- Being tested
- Myocardial contrast echocardiography, Dobutamine echocardiography
- Keywords
- CABG, Hibernation, LV Function, Microbubbles, Revascularization, Coronary Artery Disease
- Medical subject headings
- Coronary Disease, Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial contrast echocardiographyProcedure or surgery
Dobutamine echocardiographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1999
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001891
- Sponsor's protocol ID
- 990108
- Other IDs
- 99-H-0108
- Status last verified
- Mar 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Maisey M. Evaluating the benefits of nuclear cardiology. Q J Nucl Med. 1996 Mar;40(1):47-54.
PubMed 8681013Vanoverschelde JL, Wijns W, Depre C, Essamri B, Heyndrickx GR, Borgers M, Bol A, Melin JA. Mechanisms of chronic regional postischemic dysfunction in humans. New insights from the study of noninfarcted collateral-dependent myocardium. Circulation. 1993 May;87(5):1513-23. doi: 10.1161/01.cir.87.5.1513.
PubMed 8491006
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Myocardial Viability Utilizing Myocardial Contrast Echocardiography
- ClinicalTrials.gov ID
- NCT00001891
- Acronym / sponsor ID
- 990108
- Conditions
- Coronary Disease, Heart Diseases
- Keywords
- CABG, Hibernation, LV Function, Microbubbles, Revascularization, Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1999
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial contrast echocardiography | Procedure or surgery | – |
| Dobutamine echocardiography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8681013Maisey M. Evaluating the benefits of nuclear cardiology. Q J Nucl Med. 1996 Mar;40(1):47-54.
- Background: PubMed 8491006Vanoverschelde JL, Wijns W, Depre C, Essamri B, Heyndrickx GR, Borgers M, Bol A, Melin JA. Mechanisms of chronic regional postischemic dysfunction in humans. New insights from the study of noninfarcted collateral-dependent myocardium. Circulation. 1993 May;87(5):1513-23. doi: 10.1161/01.cir.87.5.1513.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myocardial contrast echocardiography and Dobutamine echocardiography in people with Coronary Disease and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.