- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Maryland
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Bethesda, Maryland, Forente stater, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Koronararteriesykdom
- Myokardiskemi
- Koronar sykdom
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Beskyttende agenter
- Adrenerge agonister
- Kardiotoniske midler
- Adrenerge beta-agonister
- Sympatomimetikk
- Adrenerge beta-1-reseptoragonister
- Dobutamin
Andre studie-ID-numre
- 990077
- 99-H-0077
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