- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00001889
Comparison of Echocardiographic Techniques in Diagnosis of Coronary Artery Disease
Comparison of Myocardial Contrast Echo With Dobutamine Echo in Diagnosis of Coronary Artery Disease
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Heart, Lung and Blood Institute (NHLBI)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Armstrong WF. Stress echocardiography for detection of coronary artery disease. Circulation. 1991 Sep;84(3 Suppl):I43-9.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies vasculaires
- Artériosclérose
- Maladies artérielles occlusives
- Maladie de l'artère coronaire
- Ischémie myocardique
- Maladie coronarienne
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agents protecteurs
- Agonistes adrénergiques
- Agents cardiotoniques
- Bêta-agonistes adrénergiques
- Sympathomimétiques
- Agonistes des récepteurs bêta-1 adrénergiques
- Dobutamine
Autres numéros d'identification d'étude
- 990077
- 99-H-0077
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