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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | January 25, 2008 | ||||
| Start Date ICMJE | April 1992 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005354 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computed Tomography (CT)--An Epidemiologic Study in the Young | ||||
| Official Title ICMJE | |||||
| Brief 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. 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. |
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| 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. |
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| Study Phase | N/A | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005354 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 4237 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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