Identification of Genes Expressed in Atherosclerotic Plaque

Completed

Conditions studied: Atherosclerosis

In brief

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

Key facts

Study ID

NCT00353730

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

69

Starts

2002-10-21

Expected to finish

2011-01-12

Last updated by the study team

2021-09-08

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Suburban Hospital — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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