- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00080587
Atherosclerosis in the Coronary and Carotid Arteries
Atherosclerosis in the Coronary and Carotid Arteries: Correlations Between Coronary IVUS, Carotid Ultrasound, and Carotid MRI
This study will compare changes in atherosclerotic plaque in the coronary arteries (vessels on the surface of the heart that supply blood to the heart) with changes in the carotid arteries (vessels in the neck that supply blood to the brain) in patients enrolled in a Pfizer-sponsored treatment trial for coronary artery disease. Atherosclerosis is a buildup of fatty deposits (plaque) in arteries that can lead to blockage of the vessel, possibly resulting in heart attack or stroke. A major question in cardiovascular disease is how closely atherosclerotic changes in the coronary arteries correlate with changes in the carotid artery that occur with treatment. substudy of a Pfizer.
Patients enrolled in the Pfizer trial comparing the effectiveness of the drug atorvastatin with a combination of atorvastatin and CETP inhibitor (a drug to increase HDL cholesterol levels) may be eligible for this substudy.
Participants undergo magnetic resonance imaging (MRI) and ultrasound of the carotid arteries to measure the thickness of the vessels. The results are then compared with the coronary artery images obtained as part of the patient's evaluation for the Pfizer trial.
MRI
MRI scans use a powerful magnet with an advanced computer system and radio waves to produce accurate, detailed pictures of organs and tissues. During the scan the patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. A medicine called gadolinium contrast may be injected into a vein during part of the scan to brighten the images. The scan takes about 30 to 90 minutes. An electrocardiogram (ECG) is done during the scan to monitor the heart's electrical activity. Patients who agree to undergo another MRI test are also imaged in a scanner that uses a stronger (3 Tesla) magnet.
Ultrasound
An echocardiogram (ultrasound of the heart) uses sound waves to image the carotid arteries. A gel is applied to the area of the neck to be imaged and a small handheld ultrasound probe is held against the neck to take the pictures.
Participants return after 2 years for a second set of tests.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
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
INCLUSION CRITERIA
Patients will be a subset of patients participating in the multicenter IVUS protocol.
Willingness to travel to the NIH to participate in the NHLBI MRI/IMT study.
EXCLUSION CRITERIA
Pacemaker
Defibrillator
Brain aneurysm clips
Implanted active medical devices (neural stimulators, cochlear implants, insulin pumps, etc.)
Severe claustrophobia
Allergy to gadolinium based contrast agents (only excludes the gadolinium portion of the test)
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Corti R, Fuster V, Fayad ZA, Worthley SG, Helft G, Smith D, Weinberger J, Wentzel J, Mizsei G, Mercuri M, Badimon JJ. Lipid lowering by simvastatin induces regression of human atherosclerotic lesions: two years' follow-up by high-resolution noninvasive magnetic resonance imaging. Circulation. 2002 Dec 3;106(23):2884-7. doi: 10.1161/01.cir.0000041255.88750.f0.
- Fayad ZA. MR imaging for the noninvasive assessment of atherothrombotic plaques. Magn Reson Imaging Clin N Am. 2003 Feb;11(1):101-13. doi: 10.1016/s1064-9689(02)00023-5.
- Wasserman BA, Smith WI, Trout HH 3rd, Cannon RO 3rd, Balaban RS, Arai AE. Carotid artery atherosclerosis: in vivo morphologic characterization with gadolinium-enhanced double-oblique MR imaging initial results. Radiology. 2002 May;223(2):566-73. doi: 10.1148/radiol.2232010659.
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 040154
- 04-H-0154
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Koronar sykdom
-
IRCCS Policlinico S. DonatoRekrutteringAnomalous aortic origin of the coronary artery (AAOCA)Italia
-
Medtronic CardiovascularFullførtArteriosclerosis of coronary artery bypass graftCanada, Forente stater
-
Lawson Health Research InstituteFullførtArteriosclerosis of arterial coronary artery bypass graftCanada
-
Deutsches Herzzentrum MuenchenFullførtArteriosclerosis of arterial coronary artery bypass graftTyskland
-
Izmir Bakircay UniversityFullførtMyocardial Bridge of Coronary ArteryTyrkia
-
William Beaumont HospitalsFullførtKoronararteriesykdom | Arteriosclerosis of coronary artery bypass graftForente stater
-
ITAB - Institute for Advanced Biomedical TechnologiesAzienda Ospedaliero, Universitaria Ospedali RiunitiFullførtMyocardial Bridge of Coronary ArteryItalia