Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090454
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2004-08-26
Brief Title:
Genetic Markers of CHD Risk in Men and Women
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-07
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 association of selected genetic markers of inflammation and endothelial activation with the occurrence of non-fatal acute myocardial infarction MI
Detailed Description:
BACKGROUND
Coronary artery disease is a major cause of death and disability in westernized societies and is growing in importance in countries with emerging economies Inflammation and endothelial dysfunction are now recognized as important contributors to coronary artery disease However the genetic basis and specific genes involved in the expression of the hyperinflammatory phenotype are not yet well-understood Identification and further characterization of variation in candidate loci that are associated with coronary artery disease would contribute to the understanding of the genetic basis underlying acute myocardial infarction and may provide novel pathways for prevention and treatment
DESIGN NARRATIVE
This case-control study will determine whether the variability in several genes that influence inflammation and endothelial dysfunction is related to the odds of myocardial infarction MI among 700 men and 229 postmenopausal women from the Western New York Health Study The study performs the following 1 To test the hypothesis that cases of acute MI will have a higher frequency of specific haplotypes at the C-reactive protein locus composed of alleles associated with higher levels of CRP production -732GA 1059GC and 1444CT than matched controls MI cases will have a greater frequency of haplotypes composed of alleles associated with higher levels of interleukin IL production specifically IL-6 production -597GA -572GC and -174GC than controls and a lower frequency of specific haplotypes in the IL1AIL1 BILL1RN gene region 2 cases will have a higher frequency of alleles and haplotypes for specific functional polymorphisms of the E-selectin gene 128R and G98T than controls 3 to utilize DNA pooling strategy for rapid screening of large numbers of single nucleotide polymorphisms SNPs in 29 candidate genes in relevant biological pathways and test selected loci for association with risk of acute MI 4 for those loci with evidence of association to identify haplotype tagging single nucleotide polymorphisms htSNPs that capture the variation at each locus and test for association between these SNPs and haplotypes and risk of MI Secondary aims will a explore the above associations among men with premature MI 55 years of age or less and b explore gene- gene and gene- environment interactions MI case subjects were identified from hospital record review in Erie and Niagara counties 95 of all eligible cases ICD9 410-4109 an average of 4 months post MI They were interviewed and examined in 1996-2001 Control subjects were randomly selected from the same counties 595 response rate and had a contemporaneous clinical exam Controls will be individually matched to cases by age sex and ethnicity
Coronary artery disease is a major cause of death and disability in westernized societies and is growing in importance in countries with emerging economies Inflammation and endothelial dysfunction are now recognized as important contributors to coronary artery disease However the genetic basis and specific genes involved in the expression of the hyperinflammatory phenotype are not yet well-understood Identification and further characterization of variation in candidate loci that are associated with coronary artery disease would contribute to the understanding of the genetic basis underlying acute myocardial infarction and may provide novel pathways for prevention and treatment
DESIGN NARRATIVE
This case-control study will determine whether the variability in several genes that influence inflammation and endothelial dysfunction is related to the odds of myocardial infarction MI among 700 men and 229 postmenopausal women from the Western New York Health Study The study performs the following 1 To test the hypothesis that cases of acute MI will have a higher frequency of specific haplotypes at the C-reactive protein locus composed of alleles associated with higher levels of CRP production -732GA 1059GC and 1444CT than matched controls MI cases will have a greater frequency of haplotypes composed of alleles associated with higher levels of interleukin IL production specifically IL-6 production -597GA -572GC and -174GC than controls and a lower frequency of specific haplotypes in the IL1AIL1 BILL1RN gene region 2 cases will have a higher frequency of alleles and haplotypes for specific functional polymorphisms of the E-selectin gene 128R and G98T than controls 3 to utilize DNA pooling strategy for rapid screening of large numbers of single nucleotide polymorphisms SNPs in 29 candidate genes in relevant biological pathways and test selected loci for association with risk of acute MI 4 for those loci with evidence of association to identify haplotype tagging single nucleotide polymorphisms htSNPs that capture the variation at each locus and test for association between these SNPs and haplotypes and risk of MI Secondary aims will a explore the above associations among men with premature MI 55 years of age or less and b explore gene- gene and gene- environment interactions MI case subjects were identified from hospital record review in Erie and Niagara counties 95 of all eligible cases ICD9 410-4109 an average of 4 months post MI They were interviewed and examined in 1996-2001 Control subjects were randomly selected from the same counties 595 response rate and had a contemporaneous clinical exam Controls will be individually matched to cases by age sex and ethnicity
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 |
|---|---|---|---|
| R01HL075389 | NIH | None | httpsreporternihgovquickSearchR01HL075389 |