Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041418
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2002-07-08
Brief Title:
Cardiac MR of Subclinical CVD Impact of Age
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
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:
None
Brief Summary:
To use magnetic resonance imaging to identify subclinical atherosclerosis and left ventricular hypertrophy in the Framingham Heart Study cohort
Detailed Description:
BACKGROUND
Coronary heart disease and stroke are leading causes of mortality for men and women in the United States Current understanding of the pathogenesis of and the risk factors for cardiovascular disease CVD is derived largely from prospective studies of clinically overt disease Unfortunately clinical risk factors for CVD defined by these methods fail to predict a large proportion of CVD events and some subjects at high clinical risk fail to develop overt disease Subclinical disease precedes clinical by yearsdecades but is difficult to quantify For example left ventricular hypertrophy LVH and aortic atherosclerosis are strong predictors of CVD events but are difficult to accurately non-invasively quantify especially among the elderly and overweight subjects both growing populations in the US MRI permits accurate assessment of cardiac anatomyfunction and subclinical aortic atherosclerosis
DESIGN NARRATIVE
The underlying hypothesis of this study is that subclinical cardiovascular disease CVD is a precursor to overt CVD and that magnetic resonance imaging MRI measures of subclinical aortic and cardiac anatomic disease are superior for the characterization of risk as compared with current measures of risk factors as well as more conventional imaging eg carotid ultrasound echo Longitudinaltime-averaged indexes of all established risk factors for CVD have been collected in the Framingham Heart Study FHS These time-averaged indexes are stronger predictors of clinical CVD than single measures In a Pilot study of 312 FHS Offspring subjects MRI measures of LV mass were successfully acquired in a larger proportion of subjects than echo and MR evidence of LVH and subclinical aortic disease correlated more strongly than echo and carotid ultrasound measures with these time-averaged indexes Application of MRI methods in the FHS offers an opportunity to identify subclinical atherosclerosis and LVH in this well-characterized cohort and to relate these data with conventional imaging measures already acquired in this cohort Importantly the near-concurrent acquisition of brain MRIneuropsychologic examination in the same FHS cohort offer the unique contemporaneous opportunity to examine subclinical cerebrovascular disease with MRI indexes of subclinical atherosclerosis The study will expand the Pilot study to perform heart and thoracicabdominal aorta MRI studies in 2400 FHS participants to allow for identification of individual CVD risk factors for subclinical atherosclerosis These population-based data will extend knowledge of the distribution and severity of atherosclerosis in adult men and women and their relations to existing echo carotid ultrasound and brain MRI measures This study provides the rare opportunity to examine associations of quantitative MRI measures of aortic atherosclerosis and LVH with both cross-sectional and time-averaged measures of individual atherosclerotic risk factors eg blood pressure cigarette smoking and cholesterol and with novel inflammatory markers eg C-reactive protein MCP-1 Further because the FHS consists of hundreds of sibships for which a DNA repository has been established the heritability of MRI indexes of atherosclerosis and LVH will be determined laying the groundwork for future genetic studies
Coronary heart disease and stroke are leading causes of mortality for men and women in the United States Current understanding of the pathogenesis of and the risk factors for cardiovascular disease CVD is derived largely from prospective studies of clinically overt disease Unfortunately clinical risk factors for CVD defined by these methods fail to predict a large proportion of CVD events and some subjects at high clinical risk fail to develop overt disease Subclinical disease precedes clinical by yearsdecades but is difficult to quantify For example left ventricular hypertrophy LVH and aortic atherosclerosis are strong predictors of CVD events but are difficult to accurately non-invasively quantify especially among the elderly and overweight subjects both growing populations in the US MRI permits accurate assessment of cardiac anatomyfunction and subclinical aortic atherosclerosis
DESIGN NARRATIVE
The underlying hypothesis of this study is that subclinical cardiovascular disease CVD is a precursor to overt CVD and that magnetic resonance imaging MRI measures of subclinical aortic and cardiac anatomic disease are superior for the characterization of risk as compared with current measures of risk factors as well as more conventional imaging eg carotid ultrasound echo Longitudinaltime-averaged indexes of all established risk factors for CVD have been collected in the Framingham Heart Study FHS These time-averaged indexes are stronger predictors of clinical CVD than single measures In a Pilot study of 312 FHS Offspring subjects MRI measures of LV mass were successfully acquired in a larger proportion of subjects than echo and MR evidence of LVH and subclinical aortic disease correlated more strongly than echo and carotid ultrasound measures with these time-averaged indexes Application of MRI methods in the FHS offers an opportunity to identify subclinical atherosclerosis and LVH in this well-characterized cohort and to relate these data with conventional imaging measures already acquired in this cohort Importantly the near-concurrent acquisition of brain MRIneuropsychologic examination in the same FHS cohort offer the unique contemporaneous opportunity to examine subclinical cerebrovascular disease with MRI indexes of subclinical atherosclerosis The study will expand the Pilot study to perform heart and thoracicabdominal aorta MRI studies in 2400 FHS participants to allow for identification of individual CVD risk factors for subclinical atherosclerosis These population-based data will extend knowledge of the distribution and severity of atherosclerosis in adult men and women and their relations to existing echo carotid ultrasound and brain MRI measures This study provides the rare opportunity to examine associations of quantitative MRI measures of aortic atherosclerosis and LVH with both cross-sectional and time-averaged measures of individual atherosclerotic risk factors eg blood pressure cigarette smoking and cholesterol and with novel inflammatory markers eg C-reactive protein MCP-1 Further because the FHS consists of hundreds of sibships for which a DNA repository has been established the heritability of MRI indexes of atherosclerosis and LVH will be determined laying the groundwork for future genetic studies
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070279 | NIH | None | httpsreporternihgovquickSearchR01HL070279 |