Identification of Genes Expressed in Atherosclerotic Plaque

NCT00353730 | Completed

• 2 other identifiers: 02026502-H-0265
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atherosclerosis

Keywords

Serial Analysis of Gene Expression; Carotid Artery Plaque; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• To identify known and unknown genes involved in the pathogenesis of atherosclerosis for further analyses.

  To identify known and unknown genes involved in the pathogenesis of atherosclerosis.

  ongoing

Secondary Outcomes (2)

• 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.

  ongoing

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients

You may qualify if:

• Any adult patient with carotid artery disease or known atherosclerosis capable of giving informed consent.
• Any adult with normal total cholesterol (less than 200 mg/dl) and blood pressure (systolic less than 140 and diastolic less than 90).
• 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.

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
• Subject with abnormal liver and renal function tests on pretreatment screening or currently taking a statin or ACE inhibitor medication.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 11239408 BACKGROUND

• 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.

  PMID: 11509446 BACKGROUND

• Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.

  PMID: 11877368 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Atherosclerosis; Carotid Stenosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Paul M Hwang, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 19, 2006
• Study Start: October 21, 2002
• Primary Completion: March 16, 2005
• Study Completion: January 12, 2011
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

US (2)