Cardiovascular DiseasesNCT00005354
Computed Tomography (CT)--An Epidemiologic Study in the Young
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Iowa.
Trial summary
To investigate the relationship between coronary heart disease risk factors and coronary artery calcification in middle age adults from the Muscatine Study. From 1992 through 1995, ultrafast computed tomography was used to measure coronary artery calcification. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Atherosclerosis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1992to May 2007
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To investigate the relationship between coronary heart disease risk factors and coronary artery calcification in middle age adults from the Muscatine Study. From 1992 through 1995, ultrafast computed tomography was used to measure coronary artery calcification. The study has been extended through January, 2001 in order to examine the role of electron beam computed tomography in detecting the presence and quantity of coronary artery calcification, a marker of the atherosclerotic process.
Read the detailed description
BACKGROUND:
Atherosclerotic heart disease, a major cause of mortality and morbidity in the United States, has been shown to have its origins in childhood. Deposition of calcium occurring early in the atheromatous process is often observed in postmortem studies of coronary arteries and the aorta. Ultrafast computed tomography (Fast-CT) provides a highly sensitive, non-invasive technique for detecting the presence and quantity of coronary artery calcification (CAC). The 'risk factors' for coronary artery disease have been determined by measuring levels of potential factors in middle-and older-aged adults and determining which predict atherosclerotic cardiovascular disease, including coronary artery disease (CAD), peripheral vascular disease, and cerebrovascular disease. Adult subjects with CAC have a greater number of coronary risk factors, including higher cholesterols. In the age group of 30-39 years, 30 to 40 percent have radiographic evidence of coronary artery or aortic calcification. In the Muscatine Study, the investigators examined coronary risk factors in 2400 subjects during childhood (ages 9-11 years) and again in young adult life (ages 20 to 30 years). This population can now provide important information related to measures of childhood and young adult coronary risk factors predicting the development of the atherosclerotic process in adults in their fourth decade of life.
DESIGN NARRATIVE:
Beginning in 1992, the longitudinal study used the non-invasive technique of ultrafast computed tomography to examine the relationship of known coronary risk factors measured in childhood and again in early adult life in order to correlate their association with coronary artery calcification. Risk factors included lipids, lipoproteins, apolipoproteins, lipoprotein(a), apo(a) genotypes, homocyst(e)ine, and left ventricular mass. Beginning in February 1996, electron beam computed tomography is used to associate risk factors with coronary artery calcification.
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Atherosclerosis, Heart Diseases
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 startApr 1992
- Primary completionMay 2007
- Study completionMay 2007
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 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
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Larry Mahoney, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005354
- Sponsor's protocol ID
- 4237
- Other IDs
- R01HL048050
- Status last verified
- Jan 2008
- First submitted
- 25 May 2000
- Last updated
- 27 Mar 2014
- Results posted
- No
Publications
Mahoney LT, Burns TL, Stanford W, Thompson BH, Witt JD, Rost CA, Lauer RM. Coronary risk factors measured in childhood and young adult life are associated with coronary artery calcification in young adults: the Muscatine Study. J Am Coll Cardiol. 1996 Feb;27(2):277-84. doi: 10.1016/0735-1097(95)00461-0.
PubMed 8557894Davis PH, Dawson JD, Mahoney LT, Lauer RM. Increased carotid intimal-medial thickness and coronary calcification are related in young and middle-aged adults. The Muscatine study. Circulation. 1999 Aug 24;100(8):838-42. doi: 10.1161/01.cir.100.8.838.
PubMed 10458720Mahoney LT, Burns TL, Stanford W, Thompson BH, Witt JD, Rost CA, Lauer RM. Usefulness of the Framingham risk score and body mass index to predict early coronary artery calcium in young adults (Muscatine Study). Am J Cardiol. 2001 Sep 1;88(5):509-15. doi: 10.1016/s0002-9149(01)01728-3.
PubMed 11524059Stanford W, Burns TL, Thompson BH, Witt JD, Lauer RM, Mahoney LT. Influence of body size and section level on calcium phantom measurements at coronary artery calcium CT scanning. Radiology. 2004 Jan;230(1):198-205. doi: 10.1148/radiol.2301020807.
PubMed 14695394
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography (CT)--An Epidemiologic Study in the Young
- ClinicalTrials.gov ID
- NCT00005354
- Acronym / sponsor ID
- 4237
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1992
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (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 investigate the relationship between coronary heart disease risk factors and coronary artery calcification in middle age adults from the Muscatine Study. From 1992 through 1995, ultrafast computed tomography was used to measure coronary artery calcification. The study has been extended through January, 2001 in order to examine the role of electron beam computed tomography in detecting the presence and quantity of coronary artery calcification, a marker of the atherosclerotic process.
Detailed description
BACKGROUND:
Atherosclerotic heart disease, a major cause of mortality and morbidity in the United States, has been shown to have its origins in childhood. Deposition of calcium occurring early in the atheromatous process is often observed in postmortem studies of coronary arteries and the aorta. Ultrafast computed tomography (Fast-CT) provides a highly sensitive, non-invasive technique for detecting the presence and quantity of coronary artery calcification (CAC). The 'risk factors' for coronary artery disease have been determined by measuring levels of potential factors in middle-and older-aged adults and determining which predict atherosclerotic cardiovascular disease, including coronary artery disease (CAD), peripheral vascular disease, and cerebrovascular disease. Adult subjects with CAC have a greater number of coronary risk factors, including higher cholesterols. In the age group of 30-39 years, 30 to 40 percent have radiographic evidence of coronary artery or aortic calcification. In the Muscatine Study, the investigators examined coronary risk factors in 2400 subjects during childhood (ages 9-11 years) and again in young adult life (ages 20 to 30 years). This population can now provide important information related to measures of childhood and young adult coronary risk factors predicting the development of the atherosclerotic process in adults in their fourth decade of life.
DESIGN NARRATIVE:
Beginning in 1992, the longitudinal study used the non-invasive technique of ultrafast computed tomography to examine the relationship of known coronary risk factors measured in childhood and again in early adult life in order to correlate their association with coronary artery calcification. Risk factors included lipids, lipoproteins, apolipoproteins, lipoprotein(a), apo(a) genotypes, homocyst(e)ine, and left ventricular mass. Beginning in February 1996, electron beam computed tomography is used to associate risk factors with coronary artery calcification.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 27 Mar 2014.
- Background: PubMed 8557894Mahoney LT, Burns TL, Stanford W, Thompson BH, Witt JD, Rost CA, Lauer RM. Coronary risk factors measured in childhood and young adult life are associated with coronary artery calcification in young adults: the Muscatine Study. J Am Coll Cardiol. 1996 Feb;27(2):277-84. doi: 10.1016/0735-1097(95)00461-0.
- Background: PubMed 10458720Davis PH, Dawson JD, Mahoney LT, Lauer RM. Increased carotid intimal-medial thickness and coronary calcification are related in young and middle-aged adults. The Muscatine study. Circulation. 1999 Aug 24;100(8):838-42. doi: 10.1161/01.cir.100.8.838.
- Background: PubMed 11524059Mahoney LT, Burns TL, Stanford W, Thompson BH, Witt JD, Rost CA, Lauer RM. Usefulness of the Framingham risk score and body mass index to predict early coronary artery calcium in young adults (Muscatine Study). Am J Cardiol. 2001 Sep 1;88(5):509-15. doi: 10.1016/s0002-9149(01)01728-3.
- Background: PubMed 14695394Stanford W, Burns TL, Thompson BH, Witt JD, Lauer RM, Mahoney LT. Influence of body size and section level on calcium phantom measurements at coronary artery calcium CT scanning. Radiology. 2004 Jan;230(1):198-205. doi: 10.1148/radiol.2301020807.
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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.
Larry Mahoney
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Iowa.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005354, 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 27 Mar 2014.