- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung
Kontakte und Standorte
Studienorte
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892
- National Heart, Lung and Blood Institute (NHLBI)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 040154
- 04-H-0154
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