Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065780
Status:
COMPLETED
Last Update Posted:
2013-10-28
First Post:
2003-07-31
Brief Title:
Ventricular Size and Value Calcification Measures by Computed Tomography - Ancillary to MESA
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-10
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 rescan 6700 subjects in the MESA study to obtain computed tomography measures of calcification
Detailed Description:
BACKGROUND
This study is ancillary to the MultiEthnic Study of Atherosclerosis MESA Trial a prospective investigation of the etiology and natural history of atherosclerosis and the ability of non-invasive tools to measure atherosclerotic burden and identify high risk individuals in a large population-based cohort The development of computed tomography CT to evaluate coronary calcification CC now provides a tool to directly measure coronary atherosclerosis non-invasively The information obtained by CT however provides more information than CC alone CT has the ability to measure and quantitate aortic valve calcification AVC mitral annular calcification MAC aortic wall calcification and left ventricular size LVS The longitudinal nature of this study will allow epidemiologic associations to be established for a multitude of risk factors and these measures establishing both the time sequence for each measure and consistency of the association in a variety of populations ethnicity gender geographical location and age Magnetic resonance imaging of the heart will also be obtained as part of the MESA trial and comparisons of LV size by CT to magnetic resonance measures will also be performed
DESIGN NARRATIVE
This study is ancillary to the MultiEthnic Study of Atherosclerosis MESA Trial a prospective investigation of the etiology and natural history of atherosclerosis and the ability of non-invasive tools to measure atherosclerotic burden and identify high risk individuals in a large population-based cohort The development of computed tomography CT to evaluate coronary calcification CC now provides a tool to directly measure coronary atherosclerosis non-invasively The information obtained by CT however provides more information than CC alone CT has the ability to measure and quantitate aortic valve calcification AVC mitral annular calcification MAC aortic wall calcification and left ventricular size LVS The longitudinal nature of this study will allow epidemiologic associations to be established for a multitude of risk factors and these measures establishing both the time sequence for each measure and consistency of the association in a variety of populations ethnicity gender geographical location and age Magnetic resonance imaging of the heart will also be obtained as part of the MESA trial and comparisons of LV size by CT to magnetic resonance measures will also be performed The investigators will utilize scans already obtained as part of the calcium scanning at baseline and 35 year follow-up and make these four measures on baseline and follow-up scans obtained The additive value of these simple measures to CC score could possibly provide clinicians with even more power to identify and stratify the high-risk cardiac patient with both findings This study will also establish the prevalence in a population based study of all both AVC and MAC using a technique highly sensitive to see these abnormalities It has been postulated that a total atherosclerotic burden could be obtained by adding CAC to thoracic aortic calcification and this total atherosclerosis score with or without MAC and AVC might better predict cardiovascular events than CAC alone Similarly this cohort of 6700 patients with repeat scans can be assessed for factors that enhance or inhibit progression of LVS mitral annular aortic valve or wall calcification lending insight into therapies that have efficacy against progression of aortic sclerosis or left ventricular enlargement
This study is ancillary to the MultiEthnic Study of Atherosclerosis MESA Trial a prospective investigation of the etiology and natural history of atherosclerosis and the ability of non-invasive tools to measure atherosclerotic burden and identify high risk individuals in a large population-based cohort The development of computed tomography CT to evaluate coronary calcification CC now provides a tool to directly measure coronary atherosclerosis non-invasively The information obtained by CT however provides more information than CC alone CT has the ability to measure and quantitate aortic valve calcification AVC mitral annular calcification MAC aortic wall calcification and left ventricular size LVS The longitudinal nature of this study will allow epidemiologic associations to be established for a multitude of risk factors and these measures establishing both the time sequence for each measure and consistency of the association in a variety of populations ethnicity gender geographical location and age Magnetic resonance imaging of the heart will also be obtained as part of the MESA trial and comparisons of LV size by CT to magnetic resonance measures will also be performed
DESIGN NARRATIVE
This study is ancillary to the MultiEthnic Study of Atherosclerosis MESA Trial a prospective investigation of the etiology and natural history of atherosclerosis and the ability of non-invasive tools to measure atherosclerotic burden and identify high risk individuals in a large population-based cohort The development of computed tomography CT to evaluate coronary calcification CC now provides a tool to directly measure coronary atherosclerosis non-invasively The information obtained by CT however provides more information than CC alone CT has the ability to measure and quantitate aortic valve calcification AVC mitral annular calcification MAC aortic wall calcification and left ventricular size LVS The longitudinal nature of this study will allow epidemiologic associations to be established for a multitude of risk factors and these measures establishing both the time sequence for each measure and consistency of the association in a variety of populations ethnicity gender geographical location and age Magnetic resonance imaging of the heart will also be obtained as part of the MESA trial and comparisons of LV size by CT to magnetic resonance measures will also be performed The investigators will utilize scans already obtained as part of the calcium scanning at baseline and 35 year follow-up and make these four measures on baseline and follow-up scans obtained The additive value of these simple measures to CC score could possibly provide clinicians with even more power to identify and stratify the high-risk cardiac patient with both findings This study will also establish the prevalence in a population based study of all both AVC and MAC using a technique highly sensitive to see these abnormalities It has been postulated that a total atherosclerotic burden could be obtained by adding CAC to thoracic aortic calcification and this total atherosclerosis score with or without MAC and AVC might better predict cardiovascular events than CAC alone Similarly this cohort of 6700 patients with repeat scans can be assessed for factors that enhance or inhibit progression of LVS mitral annular aortic valve or wall calcification lending insight into therapies that have efficacy against progression of aortic sclerosis or left ventricular enlargement
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 |
|---|---|---|---|
| R01HL071739 | NIH | None | httpsreporternihgovquickSearchR01HL071739 |