Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005349
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-05-25
Brief Title:
Epidemiology of Coronary Artery Calcification
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECAC
Brief Summary:
Using subjects from the Rochester Family Heart Study RFHS to characterize predictors of coronary artery calcification CAC a potent marker of atherosclerosis among individuals from the general population
Detailed Description:
BACKGROUND
Coronary artery disease CAD is a major cause of mortality and morbidity in the United States Current noninvasive methods to identify individuals with atherosclerosis such as exercise testing are often insensitive until plaques have progressed enough to significantly impede blood flow or impair myocardial function A large number of individuals destined to die suddenly or to experience myocardial infarction will experience no warning symptoms having only mild non-flow limiting lesions which rupture and cause occlusive clot Since coronary artery calcification CAC can identify individuals with mild non-flow limiting lesions CAC is a potent marker of atherosclerosis The presence of calcium in mild non-flow limiting lesions is hypothesized to be a predictor of coronary events in asymptomatic adults Ultrafast Cardiac Computed Tomography Ultrafast CT provides a tool to obtain sensitive noninvasive measures of both the presence and quantity of CAC
DESIGN NARRATIVE
Beginning in 1991 the study sought to establish if age and gender predict coronary artery calcification a potent marker of atherosclerosis in individuals who were sampled by the RFHS and who reported no symptoms of coronary artery disease The study also sought to establish if measures of lipid metabolism provide additional information in predicting CAC after accounting for variation in age and gender if measures of blood pressure body size fat distribution or smoking predict CAC after accounting for variation in age gender and measures of lipid metabolism if the quantity of CAC aggregates in families whether the predictors of CAC in asymptomatic individuals differ from predictors in those with symptoms of coronary artery disease Ultrafast Cardiac Computed Tomography Ultrafast CT was used to obtain sensitive noninvasive measures of both the presence and quantity of CAC
The study was renewed in 2001 through February 2005 to determine whether CAC predicts clinical events after 75 years of active followup identify genetic determinants of change in CAC quantity assess whether these genes act through measurable coronary artery disease risk factors The full sample of 1647 asymptomatic at baseline adults will be followed prospectively for clinical endpoints while CAC quantity will be re-evaluated in a sub sample of 1000 individuals
The influence of newer inflammatory markers such as fibrinogen C-reactive protein and antibodies to infective agents will be evaluated
Coronary artery disease CAD is a major cause of mortality and morbidity in the United States Current noninvasive methods to identify individuals with atherosclerosis such as exercise testing are often insensitive until plaques have progressed enough to significantly impede blood flow or impair myocardial function A large number of individuals destined to die suddenly or to experience myocardial infarction will experience no warning symptoms having only mild non-flow limiting lesions which rupture and cause occlusive clot Since coronary artery calcification CAC can identify individuals with mild non-flow limiting lesions CAC is a potent marker of atherosclerosis The presence of calcium in mild non-flow limiting lesions is hypothesized to be a predictor of coronary events in asymptomatic adults Ultrafast Cardiac Computed Tomography Ultrafast CT provides a tool to obtain sensitive noninvasive measures of both the presence and quantity of CAC
DESIGN NARRATIVE
Beginning in 1991 the study sought to establish if age and gender predict coronary artery calcification a potent marker of atherosclerosis in individuals who were sampled by the RFHS and who reported no symptoms of coronary artery disease The study also sought to establish if measures of lipid metabolism provide additional information in predicting CAC after accounting for variation in age and gender if measures of blood pressure body size fat distribution or smoking predict CAC after accounting for variation in age gender and measures of lipid metabolism if the quantity of CAC aggregates in families whether the predictors of CAC in asymptomatic individuals differ from predictors in those with symptoms of coronary artery disease Ultrafast Cardiac Computed Tomography Ultrafast CT was used to obtain sensitive noninvasive measures of both the presence and quantity of CAC
The study was renewed in 2001 through February 2005 to determine whether CAC predicts clinical events after 75 years of active followup identify genetic determinants of change in CAC quantity assess whether these genes act through measurable coronary artery disease risk factors The full sample of 1647 asymptomatic at baseline adults will be followed prospectively for clinical endpoints while CAC quantity will be re-evaluated in a sub sample of 1000 individuals
The influence of newer inflammatory markers such as fibrinogen C-reactive protein and antibodies to infective agents will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL046292-13 | NIH | None | httpsreporternihgovquickSearch5R01HL046292-13 |