Identification of Genes Expressed in Atherosclerotic Plaque
|ClinicalTrials.gov Identifier: NCT00353730|
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : September 18, 2018
|First Submitted Date||July 18, 2006|
|First Posted Date||July 19, 2006|
|Last Update Posted Date||September 18, 2018|
|Study Start Date||August 9, 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00353730 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Identification of Genes Expressed in Atherosclerotic Plaque|
|Official Title||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:
|Detailed Description||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.|
|Study Design||Observational Model: Case-Control
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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.
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.
|Ages||21 Years to 100 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||020265
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 13, 2018|