Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00041418 |
| Other study ID # |
1180 |
| Secondary ID |
R01HL070279 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
July 8, 2002 |
| Last updated |
July 28, 2016 |
| Start date |
September 2001 |
| Est. completion date |
August 2006 |
Study information
| Verified date |
January 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To use magnetic resonance imaging to identify subclinical atherosclerosis and left
ventricular hypertrophy in the Framingham Heart Study cohort.
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 years/decades 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 U.S.). MRI permits accurate assessment of cardiac anatomy/function 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 (e.g.,
carotid ultrasound, echo). Longitudinal/time-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 MRI/neuropsychologic 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 thoracic/abdominal 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 (e.g.,
blood pressure, cigarette smoking, and cholesterol) and with novel inflammatory markers
(e.g., 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.
