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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00353730 |
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
Normal Volunteers
Condition |
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Atherosclerosis |
Study Type: | Observational |
Official Title: | Identification of Genes Expressed in Atherosclerotic Plaques |
Estimated Enrollment: | 87 |
Study Start Date: | August 2002 |
Significant progress has been made in the prevention and treatment of atherosclerosis, but it continues to be a leading cause of morbidity and mortality in our society. The problem will become even more significant as an increasing proportion of the population ages. The goal of the proposed project is to advance our understanding of the genetic mechanisms of atherosclerosis. We propose to identify genes selectively expressed in peripheral monocytes of patients with atherosclerosis and in macrophages and endothelial cells of atherosclerotic plaques. We will examine gene expression profiles in purified subpopulations of cells using Serial Analysis of Gene Expression (SAGE) that requires only minute amounts of RNA, enabling the study of small homogeneous populations of cells. This sequence-based high-throughput gene expression profiling technique has the advantage of not requiring prior knowledge of the expressed gene sequences, allowing the discovery of new genes. With the completion of the human genome sequence, the SAGE technique is an ideal tool for comprehensively characterizing the transcriptomes of the important cells involved in atherosclerosis. This proposal is an exploratory study to find candidates, both known and unknown genes, which will be used for more extensive and statistically powered projects in the future. The insights obtained will be used for elucidating the pathogenesis of atherosclerosis and for developing new simple, sensitive and specific tests for early disease diagnosis. In addition, the new insights obtained may lead to the development of novel therapeutic strategies for disease prevention and treatment.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, Maryland | |
Suburban Hospital | |
Bethesda, Maryland, United States, 20814 | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 020265, 02-H-0265 |
Study First Received: | July 18, 2006 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00353730 |
Health Authority: | United States: Federal Government |
Serial Analysis of Gene Expression Carotid Artery Plaque Atherosclerosis Atherosclerosis |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis |
Cardiovascular Diseases |