Cardiovascular DiseasesNCT00005545
Arterial Endothelial Function--An Epidemiologic Study
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Iowa.
Trial summary
To determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 1998to May 2009
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Muscatine Study Longitudinal Adult Cohort - representative sample of childhood participants from the 1970s
Participated in at least on school survey examination, at least one young-adult follow-up survey examination and the first Longitudinal Adult Cohort examination
About this study
To determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood.
Read the detailed description
BACKGROUND:
Many young adult subjects have some degree of atherosclerotic coronary and carotid artery disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and only limited therapeutic process begins in youth, a measure of the early manifestations of atherosclerosis may have the potential of identifying subjects at risk for premature coronary and carotid occlusive vascular disease when therapeutic options can be administered. Impaired brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial function, which is an early manifestation of the atherosclerotic process. If impaired brachial artery FMD is a predictor of the process, then it may be used to non-invasively assess atherosclerosis early in its development and to evaluate the effect of therapeutic interventions.
DESIGN NARRATIVE:
In this longitudinal study using previously studied members of the Muscatine study, measurements are made of contemporaneous risk factors, and brachial artery FMD, along with coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the latter two established measures of early atherosclerosis) and again three years later. The effort is designed to examine the following hypotheses: 1) Established risk factor levels measured in childhood, adulthood and across the years form childhood through adulthood are predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults; and 4) Brachial artery FMD is predictive of increased carotid artery IMT.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis, Carotid Artery Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Carotid Artery Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilatation
Measured: 1999 to 2008
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 startDec 1998
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 IowaThe 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
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Trudy L Burns, University of Iowa
- Investigators
- Ronald Lauer, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005545
- Sponsor's protocol ID
- 5088
- Other IDs
- R37HL061857
- Status last verified
- Dec 2013
- First submitted
- 25 May 2000
- Last updated
- 12 Dec 2013
- Results posted
- No
Publications
Tschirren J, Lauer RM, Sonka M. Automated analysis of Doppler ultrasound velocity flow diagrams. IEEE Trans Med Imaging. 2001 Dec;20(12):1422-5. doi: 10.1109/42.974936.
PubMed 11811841
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Endothelial Function--An Epidemiologic Study
- ClinicalTrials.gov ID
- NCT00005545
- Acronym / sponsor ID
- 5088
- Conditions
- Cardiovascular Diseases, Heart Diseases, Coronary Arteriosclerosis, Carotid Artery Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 1998
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (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 determine if risk factors measured in childhood can predict the development of atherosclerotic coronary and carotid artery disease in adulthood.
Detailed description
BACKGROUND:
Many young adult subjects have some degree of atherosclerotic coronary and carotid artery disease and experience no symptoms. As time passes, many die suddenly and unexpectedly and only limited therapeutic process begins in youth, a measure of the early manifestations of atherosclerosis may have the potential of identifying subjects at risk for premature coronary and carotid occlusive vascular disease when therapeutic options can be administered. Impaired brachial artery flow mediated dilatory (FMD) capacities have been shown to exist in children and young adults with hypercholesterolemia, hyperhomocysteinemia, diabetes and in those who smoke. Impaired brachial artery FMD has been shown to related to impaired endothelial function, which is an early manifestation of the atherosclerotic process. If impaired brachial artery FMD is a predictor of the process, then it may be used to non-invasively assess atherosclerosis early in its development and to evaluate the effect of therapeutic interventions.
DESIGN NARRATIVE:
In this longitudinal study using previously studied members of the Muscatine study, measurements are made of contemporaneous risk factors, and brachial artery FMD, along with coronary artery calcification (CAC) and carotid artery intimal-medial thickness (IMT) (the latter two established measures of early atherosclerosis) and again three years later. The effort is designed to examine the following hypotheses: 1) Established risk factor levels measured in childhood, adulthood and across the years form childhood through adulthood are predictive of brachial artery flow mediated dilatory (FMD) capacities; 2) Putative risk factor levels measured in adulthood are related to the degree of brachial artery FMD, CAC and carotid artery IMT; 3) Brachial artery FMD, CAC and carotid artery IMTare related in adults; and 4) Brachial artery FMD is predictive of increased carotid artery IMT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Muscatine Study Longitudinal Adult Cohort - representative sample of childhood participants from the 1970s
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
Flow-mediated dilatation
Time frame: 1999 to 2008
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 12 Dec 2013.
- Background: PubMed 11811841Tschirren J, Lauer RM, Sonka M. Automated analysis of Doppler ultrasound velocity flow diagrams. IEEE Trans Med Imaging. 2001 Dec;20(12):1422-5. doi: 10.1109/42.974936.
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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.
Ronald Lauer principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Iowa.
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 12 Dec 2013. 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?
Flow-mediated dilatation (time frame: 1999 to 2008). 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 NCT00005545, which also lists 1 linked publication.
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 12 Dec 2013.