- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00353730
Identification of Genes Expressed in Atherosclerotic Plaque
Identification of Genes Expressed in Atherosclerotic Plaques
This study will identify genes and proteins in the blood of patients with atherosclerosis and in that of normal volunteers. The findings will be compared to determine the influence of these substances on the development of atherosclerosis a narrowing and hardening of blood vessel walls by deposits of fatty substances. Blood vessel blockage caused by atherosclerosis can impede blood flow and cause stroke, heart attack and poor limb circulation. The information from this study may lead to better ways to detect, prevent and treat these diseases.
Healthy volunteers and patients scheduled for carotid endarterectomy at Suburban Hospital in Bethesda, Maryland, are eligible for this study. Carotid endarterectomy is a surgical procedure in which the inner layer of the carotid artery (neck artery supplying blood to the brain) is scraped away to open the blocked vessel. Participants will undergo the following tests and procedures:
Patients
- Blood sample: Collection of about 32 cc (8 tablespoons) of blood for genetic and protein analysis
- Tissue sample: Collection of a piece of diseased blood vessel discarded from the endarterectomy procedure
- Review of records: Review of medical records for information about past illnesses, medications, tests, and so forth, if needed
Normal Volunteers
- Blood samples: Collection of about 32 cc (8 tablespoons) of blood for genetic and protein analysis
- Carotid artery ultrasound: Ultrasound imaging of the neck arteries for detection of any blockage
- Electrocardiogram: Recording of the electrical activity of the heart to detect any abnormalities in heart rhythm
- Echocardiogram: Ultrasound examination to detect possible abnormalities of the heart muscle
- Cardiac stress test: Treadmill stress test to detect possible heart vessel blockage (for subjects who have not had a cardiac stress test in the past year)
- Review of records: Review of medical records for information about past illnesses, medications, tests, and so forth, if needed
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Maryland
-
Bethesda, Maryland, Förenta staterna, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
Bethesda, Maryland, Förenta staterna, 20814
- Suburban Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
- INCLUSION CRITERIA:
Any adult patient with carotid artery disease or known atherosclerosis capable of giving informed consent.
INCLUSION CRITERIA FOR MEDICATION TREATED SUBJECT:
Any adult with normal total cholesterol (less than 200 mg/dl) and blood pressure (systolic less than 140 and diastolic less than 90).
INCLUSION CRITERIA FOR NORMAL BRONCHOSCOPY SUBJECT:
Any healthy adult subject with no history of peripheral or coronary artery disease, who is eligible for bronchoalveolar lavage per Protocol 99-H-0068 and capable of giving informed consent.
EXCLUSION CRITERIA:
Unable to give consent
History of chronic infections, vasculitis or any other inflammatory disease
History of neoplastic disease or chemotherapy treatment
Immunosuppressive medications other than common over-the-counter drugs such as aspirin or acetaminophen
EXCLUSION CRITERIA FOR MEDICATION TREATED SUBJECT:
Subject with abnormal liver and renal function tests on pretreatment screening or currently taking a statin or ACE inhibitor medication.
EXCLUSION CRITERIA FOR NORMAL BRONCHOSCOPY SUBJECT:
Any exclusion criteria for normal subject listed in Protocol 99-H-0068.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To identify known and unknown genes involved in the pathogenesis of atherosclerosis for further analyses.
Tidsram: ongoing
|
To identify known and unknown genes involved in the pathogenesis of atherosclerosis.
|
ongoing
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To identify atherosclerosis-specific genes expressed in peripheral monocytes, plaque macrophages or endothelial cells that may serve as early markers for disease diagnosis
Tidsram: ongoing
|
To identify atherosclerosis-specific genes expressed in peripheral monocytes, plaque macrophages or endothelial cells that may serve as early markers for disease diagnosis
|
ongoing
|
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
Tidsram: ongoing
|
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
|
ongoing
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Paul M Hwang, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publikationer och användbara länkar
Allmänna publikationer
- Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
- Glass CK, Witztum JL. Atherosclerosis. the road ahead. Cell. 2001 Feb 23;104(4):503-16. doi: 10.1016/s0092-8674(01)00238-0. No abstract available.
- Fayad ZA, Fuster V. Clinical imaging of the high-risk or vulnerable atherosclerotic plaque. Circ Res. 2001 Aug 17;89(4):305-16. doi: 10.1161/hh1601.095596.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 020265
- 02-H-0265
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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