AtherosclerosisNCT00925561
Examining the Genetic Predictors of Coronary Artery Calcification in African Americans
An observational study of Atherosclerosis, run by University of Michigan at 1 site in United States.
Trial summary
Coronary artery disease (CAD) is an important health concern for African Americans, who are diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by calcium deposits in the coronary arteries, is a contributing factor to CAD. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 752 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will come from Jackson, MS and will include all men and women belonging to sibships that previously participated in the second GENOA exam. The sampling frame includes 1482 African Americans in 627 sibships providing 1552 sibling pairs from Jackson, Mississippi.
Who may be able to join
- Participated in the second GENOA exam in Jackson, Mississippi and is alive and willing to participate
Who cannot join
- Reported a history of heart attack, stroke, or coronary or non-coronary heart surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Predictors of Coronary Artery Calcification in an African American Cohort
Coronary artery disease (CAD) is an important health concern for African Americans, who are diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by calcium deposits in the coronary arteries, is a contributing factor to CAD. This study will examine the possible genetic causes of coronary artery calcification in African Americans.
Read the detailed description
In the United States, more people die from CAD than any other disease, with African Americans, particularly women and young men, being more affected by CAD than European Americans. One cause of CAD is atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. Coronary artery calcification occurs as a result of atherosclerosis and is characterized by calcium build up in the arteries. Non-invasive imaging, including computed tomography (CT) scans, of coronary artery calcification is an effective way to assess CAD risk. The Genetic Epidemiology Network of Arteriopathy (GENOA) study, which is part of the Family Blood Pressure Program (FBPP), is a study that examined siblings with high blood pressure during two exams conducted between 1995 and 2004. The purpose of this new GENOA study, which will enroll past GENOA participants, is to identify genetic factors that may lead to the development of coronary artery calcification in African Americans. Conducting genetic studies in the African American population will result in greater understanding of the mechanisms of atherosclerosis, and may lead to improved strategies for the early identification of people at risk for CAD and the development of new treatments for CAD.
This study will enroll people who have participated in the second GENOA exam and who live in Jackson, Mississippi. Participants will attend one study visit at the University of Mississippi Medical Center. During the study visit, participants will be interviewed by study staff about their medical and family health history; health behaviors; physical activity levels; and use of tobacco, alcohol, and medications. They will complete a walking activity and tasks to assess memory, thinking speed, and accuracy. Participants will also complete a questionnaire about their mood, a physical examination, a CT scan of the heart, and a blood collection. A portion of blood will be stored for future research studies.
- Conditions
- Atherosclerosis
- Keywords
- Coronary Artery Calcification
- Medical subject headings
- Atherosclerosis
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 |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Calcification
Measured: Measured during participants' single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2013
- Study completionApr 2013
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 University of MichiganThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Mississippi Medical Center, Wake Forest University, Mayo Clinic
- Responsible party
- Principal investigator, Patricia Peyser, University of Michigan
- Investigators
- Patricia Peyser, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925561
- Sponsor's protocol ID
- 643
- Other IDs
- R01HL085571, 5R01HL085571
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Coronary Artery Calcification in an African American Cohort
- ClinicalTrials.gov ID
- NCT00925561
- Acronym / sponsor ID
- 643
- Conditions
- Atherosclerosis
- Keywords
- Coronary Artery Calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Mississippi Medical Center, Wake Forest University, Mayo Clinic
- Study start
- Jan 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Jun 2009 (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.
Coronary artery disease (CAD) is an important health concern for African Americans, who are diagnosed with CAD at high rates. Coronary artery calcification, which is characterized by calcium deposits in the coronary arteries, is a contributing factor to CAD. This study will examine the possible genetic causes of coronary artery calcification in African Americans.
Detailed description
In the United States, more people die from CAD than any other disease, with African Americans, particularly women and young men, being more affected by CAD than European Americans. One cause of CAD is atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. Coronary artery calcification occurs as a result of atherosclerosis and is characterized by calcium build up in the arteries. Non-invasive imaging, including computed tomography (CT) scans, of coronary artery calcification is an effective way to assess CAD risk. The Genetic Epidemiology Network of Arteriopathy (GENOA) study, which is part of the Family Blood Pressure Program (FBPP), is a study that examined siblings with high blood pressure during two exams conducted between 1995 and 2004. The purpose of this new GENOA study, which will enroll past GENOA participants, is to identify genetic factors that may lead to the development of coronary artery calcification in African Americans. Conducting genetic studies in the African American population will result in greater understanding of the mechanisms of atherosclerosis, and may lead to improved strategies for the early identification of people at risk for CAD and the development of new treatments for CAD.
This study will enroll people who have participated in the second GENOA exam and who live in Jackson, Mississippi. Participants will attend one study visit at the University of Mississippi Medical Center. During the study visit, participants will be interviewed by study staff about their medical and family health history; health behaviors; physical activity levels; and use of tobacco, alcohol, and medications. They will complete a walking activity and tasks to assess memory, thinking speed, and accuracy. Participants will also complete a questionnaire about their mood, a physical examination, a CT scan of the heart, and a blood collection. A portion of blood will be stored for future research studies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will come from Jackson, MS and will include all men and women belonging to sibships that previously participated in the second GENOA exam. The sampling frame includes 1482 African Americans in 627 sibships providing 1552 sibling pairs from Jackson, Mississippi.
Key inclusion criteria (1 listed)
- Participated in the second GENOA exam in Jackson, Mississippi and is alive and willing to participate
Key exclusion criteria (1 listed)
- Reported a history of heart attack, stroke, or coronary or non-coronary heart surgery
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
Coronary Artery Calcification
Time frame: Measured during participants' single study visit
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 19 Jun 2013.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
Patricia Peyser, Ph.D. principal investigator
University of Michigan
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, run by University of Michigan 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 1 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 19 Jun 2013. 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?
Coronary Artery Calcification (time frame: Measured during participants' single study visit). 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 19 Jun 2013.