AtherosclerosisNCT00613158
Using Differences in Peripheral Blood Leukocyte Gene Expression to Determine Cardiovascular Disease Risk
An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries. Traditional risk factors for CVD include age, high blood pressure, high cholesterol, diabetes, and smoking. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Feb 2010
- 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 20 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include female participants from MESA with and without SA. This study will also include healthy female participants from Northwestern University.
Who may be able to join
- Female participant from the MESA study who has a low Framingham risk score and has either SA or no evidence of SA
- Healthy female below the age of 40 from Northwestern University.
Who cannot join
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atherosclerosis Risk Refinement - a Multi-marker Approach Using Microarrays
Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries. Traditional risk factors for CVD include age, high blood pressure, high cholesterol, diabetes, and smoking. Although these established risk factors can be helpful in determining people at risk for developing CVD, the addition of novel gene markers for subclinical, or suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease mechanisms. This study will compare specific genes of white blood cells in people with significant SA versus people without SA to improve identification of those at risk for developing CVD and to better understand the biological basis of SA.
Read the detailed description
CVD is the leading cause of death worldwide and accounts for almost 40% of deaths each year in the United States. In a person with CVD, oxygenated blood is not adequately distributed throughout the body because of impaired function in the heart and blood vessels. This restricted blood flow can eventually lead to organ damage, heart attack, and stroke. Risk prediction for CVD, which is largely associated with SA, relies on the use of certain traditional risk factors. The widely used Framingham risk score (FRS) has provided excellent risk discrimination and reliable estimates of 10-year risk for CVD, but it does not account for the genetics behind SA. Although numerous studies have investigated novel genetic biomarkers to attempt to add predictive value to the FRS, no single biomarker to date has been able to improve risk prediction in a meaningful way. A multi-marker approach that identifies several novel markers unrelated to traditional risk factors may be more effective in improving the identification of those at risk for CVD. This study will first construct a multi-marker approach that is based on patterns of gene expression in peripheral blood leukocytes (PBLs) and that can serve to identify people with substantial SA. The study will then use this approach to determine whether gene expression patterns of PBLs in people with SA are distinct from those in people without SA.
This study will use previously collected data and specimens, including blood samples and SA imaging, from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) trial and from healthy female participants from Northwestern University. Blood samples will be used for analysis of patterns of gene expression in PBLs. There will be no new study visits for this study.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Keywords
- Subclincal Atherosclerosis
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants from the Multi-Ethnic Study of Atherosclerosis (MESA) with significant subclinical atherosclerosis (SA) and a low Framingham risk score | |
| 2 | Participants from MESA with no SA and a low Framingham risk score | |
| 3 | Healthy participants from Northwestern University |
What is being measured
The primary outcome is the main question the study is designed to answer.
SA burden, as indicated by coronary artery calcium score and intima-medial thickness
Measured: Measured at completion of sample analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionAug 2007
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Chiang-Ching Huang, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613158
- Sponsor's protocol ID
- 1384
- Other IDs
- R01HL086678-01A1
- Status last verified
- Apr 2009
- First submitted
- 8 Feb 2008
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis Risk Refinement - a Multi-marker Approach Using Microarrays
- ClinicalTrials.gov ID
- NCT00613158
- Acronym / sponsor ID
- 1384
- Conditions
- Atherosclerosis, Cardiovascular Diseases
- Keywords
- Subclincal Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 12 Feb 2008 (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.
Cardiovascular disease (CVD), including heart disease, heart attack, high blood pressure, and stroke, is most commonly caused by atherosclerosis, or a hardening of the arteries. Traditional risk factors for CVD include age, high blood pressure, high cholesterol, diabetes, and smoking. Although these established risk factors can be helpful in determining people at risk for developing CVD, the addition of novel gene markers for subclinical, or suspected, atherosclerosis (SA) may enhance CVD risk prediction and understanding of disease mechanisms. This study will compare specific genes of white blood cells in people with significant SA versus people without SA to improve identification of those at risk for developing CVD and to better understand the biological basis of SA.
Detailed description
CVD is the leading cause of death worldwide and accounts for almost 40% of deaths each year in the United States. In a person with CVD, oxygenated blood is not adequately distributed throughout the body because of impaired function in the heart and blood vessels. This restricted blood flow can eventually lead to organ damage, heart attack, and stroke. Risk prediction for CVD, which is largely associated with SA, relies on the use of certain traditional risk factors. The widely used Framingham risk score (FRS) has provided excellent risk discrimination and reliable estimates of 10-year risk for CVD, but it does not account for the genetics behind SA. Although numerous studies have investigated novel genetic biomarkers to attempt to add predictive value to the FRS, no single biomarker to date has been able to improve risk prediction in a meaningful way. A multi-marker approach that identifies several novel markers unrelated to traditional risk factors may be more effective in improving the identification of those at risk for CVD. This study will first construct a multi-marker approach that is based on patterns of gene expression in peripheral blood leukocytes (PBLs) and that can serve to identify people with substantial SA. The study will then use this approach to determine whether gene expression patterns of PBLs in people with SA are distinct from those in people without SA.
This study will use previously collected data and specimens, including blood samples and SA imaging, from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) trial and from healthy female participants from Northwestern University. Blood samples will be used for analysis of patterns of gene expression in PBLs. There will be no new study visits for this study.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants from the Multi-Ethnic Study of Atherosclerosis (MESA) with significant subclinical atherosclerosis (SA) and a low Framingham risk score |
| 2 | – | –Participants from MESA with no SA and a low Framingham risk score |
| 3 | – | –Healthy participants from Northwestern University |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include female participants from MESA with and without SA. This study will also include healthy female participants from Northwestern University.
Key inclusion criteria (2 listed)
- Female participant from the MESA study who has a low Framingham risk score and has either SA or no evidence of SA
- Healthy female below the age of 40 from Northwestern University.
Key exclusion criteria (1 listed)
- Diabetes
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
SA burden, as indicated by coronary artery calcium score and intima-medial thickness
Time frame: Measured at completion of sample analysis
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 29 Jul 2016.
Related trials for Atherosclerosis
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Active, not recruitingPhase 3
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Atherosclerotic Cardiovascular Disease, Overweight
Active, not recruitingObservational study
A Retrospective Cohort Study Evaluating Major Adverse Cardiovascular Events and Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events (OPTIMUS RISK - Spain)
Atherosclerotic Cardiovascular Disease
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.
Chiang-Ching Huang, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site 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 2 inclusion and 1 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
SA burden, as indicated by coronary artery calcium score and intima-medial thickness (time frame: Measured at completion of sample analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2016.