Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005676
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2000-05-25
Brief Title:
High Density Lipoprotein Subspecies and Coronary Disease
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
High Density Lipoprotein Subspecies and Coronary Disease
Status:
COMPLETED
Status Verified Date:
2014-03
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 investigate the relative contributions of high density lipoprotein-C HDL-C subspecies to risk for coronary heart disease CHD in two distinct existing populations samples from the VA-HIT study and the Framingham Offspring Study FOS as well as the response of these subfractions to gemfibrozil treatment
Detailed Description:
BACKGROUND
Coronary heart disease CHD continues to be a leading cause of death and disability in the United States Information about the contribution of different subspecies of HDL-C to increased or decreased risk for premature CHD and the extent to which common lipoprotein lipase LPL mutations affect HDL-C composition and subspecies could contribute to an increased understanding of the role of HDL-C in determining CHD risk
DESIGN NARRATIVE
The following parameters will be measured in blood samples collected from the VA-HIT study and the Framingham Offspring Study apo A-I-containing HDL subspecies prebeta alpha and prealpha in plasma using two-dimensional gel electrophoresis immunoblot and image analysis LpA-I and LpA-IA-II in plasma using differential electroimmunoassay and apo C-III in HDL using immunoturbidometric assay The study hypotheses are as follow a Subjects from the placebo arm of VA-HIT will have significantly lower alpha l HDL subspecies LpA-I and apo C-III in HDL and higher HDLalpha l and apo A-Ialpha l ratios than subjects free of coronary heart disease from the Framingham Offspring Study b These parameters will also predict prospectively risk of coronary heart disease in both groups c In the VA-HIT study treatment with gemfibrozil which has been shown to be associated with a 22 percent reduction in myocardial infarction and coronary heart disease death will be associated with increases in alpha l HDL subspecies LpA-I and apo C-III in HDL as well as decreases in HDLalpha l and apo A-Ialpha l ratios compared to placebo d The hypothesis that subjects with specific mutations in the lipoprotein lipase gene have less beneficial changes in HDL subspecies with gemfibrozil than subjects with no mutations will also be tested
Coronary heart disease CHD continues to be a leading cause of death and disability in the United States Information about the contribution of different subspecies of HDL-C to increased or decreased risk for premature CHD and the extent to which common lipoprotein lipase LPL mutations affect HDL-C composition and subspecies could contribute to an increased understanding of the role of HDL-C in determining CHD risk
DESIGN NARRATIVE
The following parameters will be measured in blood samples collected from the VA-HIT study and the Framingham Offspring Study apo A-I-containing HDL subspecies prebeta alpha and prealpha in plasma using two-dimensional gel electrophoresis immunoblot and image analysis LpA-I and LpA-IA-II in plasma using differential electroimmunoassay and apo C-III in HDL using immunoturbidometric assay The study hypotheses are as follow a Subjects from the placebo arm of VA-HIT will have significantly lower alpha l HDL subspecies LpA-I and apo C-III in HDL and higher HDLalpha l and apo A-Ialpha l ratios than subjects free of coronary heart disease from the Framingham Offspring Study b These parameters will also predict prospectively risk of coronary heart disease in both groups c In the VA-HIT study treatment with gemfibrozil which has been shown to be associated with a 22 percent reduction in myocardial infarction and coronary heart disease death will be associated with increases in alpha l HDL subspecies LpA-I and apo C-III in HDL as well as decreases in HDLalpha l and apo A-Ialpha l ratios compared to placebo d The hypothesis that subjects with specific mutations in the lipoprotein lipase gene have less beneficial changes in HDL subspecies with gemfibrozil than subjects with no mutations will also be tested
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 |
|---|---|---|---|
| R01HL064738 | NIH | None | httpsreporternihgovquickSearchR01HL064738 |