AtherosclerosisNCT00353730
Identification of Genes Expressed in Atherosclerotic Plaque
An observational study of Atherosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Atherosclerosis
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2002to 12 Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients
Who may be able to join
- 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.
Who cannot join
- 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.
- Any exclusion criteria for normal subject listed in Protocol 99-H-0068.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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:
Read more
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
Read the 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.
- Conditions
- Atherosclerosis
- Keywords
- Serial Analysis of Gene Expression, Carotid Artery Plaque, Atherosclerosis
- Medical subject headings
- Atherosclerosis, Carotid Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To identify atherosclerosis-specific genes expressed in peripheral monocytes, plaque macrophages or endothelial cells that may serve as early markers for disease diagnosis
Measured: ongoing
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study start21 Oct 2002
- Primary completion16 Mar 2005
- Study completion12 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paul M Hwang, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353730
- Sponsor's protocol ID
- 020265
- Other IDs
- 02-H-0265
- Status last verified
- Sep 2021
- First submitted
- 18 Jul 2006
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11239408Fayad 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.
PubMed 11509446Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
PubMed 11877368
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genes Expressed in Atherosclerotic Plaques
- ClinicalTrials.gov ID
- NCT00353730
- Acronym / sponsor ID
- 020265
- Conditions
- Atherosclerosis
- Keywords
- Serial Analysis of Gene Expression, Carotid Artery Plaque, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 21 Oct 2002 (actual)
- Primary completion
- 16 Mar 2005 (actual)
- Study completion
- 12 Jan 2011 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify known and unknown genes involved in the pathogenesis of atherosclerosis for further analyses.
Time frame: ongoing
To identify known and unknown genes involved in the pathogenesis of atherosclerosis.
2 secondary outcomes
To identify atherosclerosis-specific genes expressed in peripheral monocytes, plaque macrophages or endothelial cells that may serve as early markers for disease diagnosis
Time frame: ongoing
To identify genes expressed early in the pathogenesis of atherosclerosis that may be targeted for disease prevention.
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 11239408Glass 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.
- Background: PubMed 11509446Fayad 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.
- Background: PubMed 11877368Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul M Hwang, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify known and unknown genes involved in the pathogenesis of atherosclerosis for further analyses. (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00353730, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.