Cardiovascular DiseasesNCT00005393
Epidemiology: Oxidative Stress and Early Atherosclerosis
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
Trial summary
To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white, male and female, high and low education individuals aged 18-30 in 1985-86. Read more about this study
- Who is it for?
- Ages 17 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis
- How many people
- 5,115 participants
- Where
- No sites listed yet
- Study dates
- Aug 1996to 31 Dec 2021
- 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 17 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study sample was selected from residents of Minneapolis, MN, Birmingham, AL, Chicago, IL and Oakland, CA in 1985-86 as a community based sample.
No eligibility criteria
About this study
To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white, male and female, high and low education individuals aged 18-30 in 1985-86. In subsequent renewals additional markers of oxidative stress and endothelial dysfunction have been measured in blood collected 7 to 30 years after baseline.
Read the detailed description
BACKGROUND:
Low blood antioxidant concentrations are associated with several major degenerative diseases including cardiovascular disease and cancer. Animal, cellular and chemical experiments have elucidated biologic mechanisms consistent with antioxidant protection against several disease processes. Determinants of blood antioxidant concentrations are not well understood in young adults.
The main scientific outcome of this research will be information on distribution and correlates of blood antioxidant concentrations, useful for formulating public health messages concerning maintenance of adequate levels of alpha tocopherol, selenium, ascorbic acid and the carotenoids.
DESIGN NARRATIVE:
An analysis was conducted using serum stored at 70 degrees Celsius, collected in 1985-86 (n=5115) and 1992-93 (n=4086). These analytes were stable in serum samples collected, handled and stored under conditions used in this study. Integrity of the chemical analysis throughout the study was maintained by proven laboratory quality control procedures. Monitoring analyte concentrations in serum from collections seven years apart allowed analysis of age and time dependent changes in serum antioxidants. These data were linked with extensive pre-existing sociodemographic, dietary, other behavioral and physiologic data for the cohort. Statistical analyses provided information on the population's serum antioxidant distribution, tracking, change and major determinants in diverse young adults. In addition, these data established baseline and 7-year change concentration values for followup of this large CARDIA cohort, though the relationship of these serum antioxidants to disease endpoints was not itself part of the work scope. Study of plasma ascorbic acid, which is not stable under our storage conditions, was initiated using fresh samples to be collected in 1995-96 (n=4000).
The Young Adult Longitudinal Study of Antioxidants (YALTA), ancillary to CARDIA study, was renewed in fiscal year 2000 to obtain additional blood and urine samples in the year 15 exam of the CARDIA participants. New measures of circulating lipid, protein, and DNA oxidation products (F2-isoprostanes, advanced glycosylation end-products [AGE], chlorinated and nitrosylated tyrosine, platelet aggregating factor (PAF) acetylhydrolase, paroxonase), urinary DNA damage, soluble intercellular adhesion molecule (ICAM), soluble P-selectin, and relevant genetic polymorphisms. The specific endpoints at the 15 year exam were coronary artery calcification as measured by computed tomography and microalbuminuria.
The study was renewed in 2004 through 2008. Blood and urine was collected from subjects at the CARDIA year 20 exam to remeasure blood F2 isoprostanes, phospholipase A2, superoxide dismutase and carotenoids and tocopherols. Oxidized low density lipoprotein (LDL) and myeloperoxidase was also measured and analysis conducted of the association of antioxidant and oxidative damage levels and the development of subclinical macrovascular disease in this still-young group.
The study renewed for a fourth time in 2010 through 2015, and a renewal application for a fifth renewal period was submitted in summer, 2014. It continues to write reports about different feature of oxidative stress and related phenomena as the CARDIA subjects age.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cardiovascular disease
Events are ascertained in annual direct contact with the participant. Medical records are obtained and adjudicated for event status.
Measured: Annual participant contact
Secondary outcomes (1)
subclinical cardiovascular disease
Various subclinical measures are performed, including cardiac echocardiography and coronary computed tomography
Measured: every 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startAug 1996
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Prospective
- Enrolment
- 5,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Jacobs, PhD, Principal investigator, University of MinnesotaMyron D Gross, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005393
- Sponsor's protocol ID
- 4299
- Status last verified
- Feb 2022
- First submitted
- 25 May 2000
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee DH, Jacobs DR Jr, Gross M, Kiefe CI, Roseman J, Lewis CE, Steffes M. Gamma-glutamyltransferase is a predictor of incident diabetes and hypertension: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2003 Aug;49(8):1358-66. doi: 10.1373/49.8.1358.
PubMed 12881453Svilaas A, Sakhi AK, Andersen LF, Svilaas T, Strom EC, Jacobs DR Jr, Ose L, Blomhoff R. Intakes of antioxidants in coffee, wine, and vegetables are correlated with plasma carotenoids in humans. J Nutr. 2004 Mar;134(3):562-7. doi: 10.1093/jn/134.3.562.
PubMed 14988447Lee DH, Gross MD, Jacobs DR Jr; Cardiovascular Risk Development in Young Adults Study. Association of serum carotenoids and tocopherols with gamma-glutamyltransferase: the Cardiovascular Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2004 Mar;50(3):582-8. doi: 10.1373/clinchem.2003.028852. Epub 2004 Jan 15.
PubMed 14726472Lee DH, Jacobs DR Jr, Gross M, Steffes M. Serum gamma-glutamyltransferase was differently associated with microalbuminuria by status of hypertension or diabetes: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2005 Jul;51(7):1185-91. doi: 10.1373/clinchem.2004.045872. Epub 2005 May 12.
PubMed 15890893
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology: Oxidative Stress and Early Atherosclerosis
- ClinicalTrials.gov ID
- NCT00005393
- Acronym / sponsor ID
- 4299
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,115 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Northwestern University, Kaiser Permanente, University of Alabama at Birmingham
- Study start
- Aug 1996 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 May 2000 (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.
To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white, male and female, high and low education individuals aged 18-30 in 1985-86. In subsequent renewals additional markers of oxidative stress and endothelial dysfunction have been measured in blood collected 7 to 30 years after baseline.
Detailed description
BACKGROUND:
Low blood antioxidant concentrations are associated with several major degenerative diseases including cardiovascular disease and cancer. Animal, cellular and chemical experiments have elucidated biologic mechanisms consistent with antioxidant protection against several disease processes. Determinants of blood antioxidant concentrations are not well understood in young adults.
The main scientific outcome of this research will be information on distribution and correlates of blood antioxidant concentrations, useful for formulating public health messages concerning maintenance of adequate levels of alpha tocopherol, selenium, ascorbic acid and the carotenoids.
DESIGN NARRATIVE:
An analysis was conducted using serum stored at 70 degrees Celsius, collected in 1985-86 (n=5115) and 1992-93 (n=4086). These analytes were stable in serum samples collected, handled and stored under conditions used in this study. Integrity of the chemical analysis throughout the study was maintained by proven laboratory quality control procedures. Monitoring analyte concentrations in serum from collections seven years apart allowed analysis of age and time dependent changes in serum antioxidants. These data were linked with extensive pre-existing sociodemographic, dietary, other behavioral and physiologic data for the cohort. Statistical analyses provided information on the population's serum antioxidant distribution, tracking, change and major determinants in diverse young adults. In addition, these data established baseline and 7-year change concentration values for followup of this large CARDIA cohort, though the relationship of these serum antioxidants to disease endpoints was not itself part of the work scope. Study of plasma ascorbic acid, which is not stable under our storage conditions, was initiated using fresh samples to be collected in 1995-96 (n=4000).
The Young Adult Longitudinal Study of Antioxidants (YALTA), ancillary to CARDIA study, was renewed in fiscal year 2000 to obtain additional blood and urine samples in the year 15 exam of the CARDIA participants. New measures of circulating lipid, protein, and DNA oxidation products (F2-isoprostanes, advanced glycosylation end-products [AGE], chlorinated and nitrosylated tyrosine, platelet aggregating factor (PAF) acetylhydrolase, paroxonase), urinary DNA damage, soluble intercellular adhesion molecule (ICAM), soluble P-selectin, and relevant genetic polymorphisms. The specific endpoints at the 15 year exam were coronary artery calcification as measured by computed tomography and microalbuminuria.
The study was renewed in 2004 through 2008. Blood and urine was collected from subjects at the CARDIA year 20 exam to remeasure blood F2 isoprostanes, phospholipase A2, superoxide dismutase and carotenoids and tocopherols. Oxidized low density lipoprotein (LDL) and myeloperoxidase was also measured and analysis conducted of the association of antioxidant and oxidative damage levels and the development of subclinical macrovascular disease in this still-young group.
The study renewed for a fourth time in 2010 through 2015, and a renewal application for a fifth renewal period was submitted in summer, 2014. It continues to write reports about different feature of oxidative stress and related phenomena as the CARDIA subjects age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study sample was selected from residents of Minneapolis, MN, Birmingham, AL, Chicago, IL and Oakland, CA in 1985-86 as a community based sample.
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
Clinical cardiovascular disease
Time frame: Annual participant contact
Events are ascertained in annual direct contact with the participant. Medical records are obtained and adjudicated for event status.
1 secondary outcome
subclinical cardiovascular disease
Time frame: every 5 years
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 10 Feb 2022.
- Background: PubMed 12881453Lee DH, Jacobs DR Jr, Gross M, Kiefe CI, Roseman J, Lewis CE, Steffes M. Gamma-glutamyltransferase is a predictor of incident diabetes and hypertension: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2003 Aug;49(8):1358-66. doi: 10.1373/49.8.1358.
- Background: PubMed 14988447Svilaas A, Sakhi AK, Andersen LF, Svilaas T, Strom EC, Jacobs DR Jr, Ose L, Blomhoff R. Intakes of antioxidants in coffee, wine, and vegetables are correlated with plasma carotenoids in humans. J Nutr. 2004 Mar;134(3):562-7. doi: 10.1093/jn/134.3.562.
- Background: PubMed 14726472Lee DH, Gross MD, Jacobs DR Jr; Cardiovascular Risk Development in Young Adults Study. Association of serum carotenoids and tocopherols with gamma-glutamyltransferase: the Cardiovascular Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2004 Mar;50(3):582-8. doi: 10.1373/clinchem.2003.028852. Epub 2004 Jan 15.
- Background: PubMed 15890893Lee DH, Jacobs DR Jr, Gross M, Steffes M. Serum gamma-glutamyltransferase was differently associated with microalbuminuria by status of hypertension or diabetes: the Coronary Artery Risk Development in Young Adults (CARDIA) Study. Clin Chem. 2005 Jul;51(7):1185-91. doi: 10.1373/clinchem.2004.045872. Epub 2005 May 12.
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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.
David R Jacobs, PhD principal investigator
University of Minnesota
Myron D Gross, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical cardiovascular disease (time frame: Annual participant contact). 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 NCT00005393, which also lists 4 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 10 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.