Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094198
Status:
COMPLETED
Last Update Posted:
2008-08-21
First Post:
2004-10-15
Brief Title:
Pharmacogenetics and Cardiovascular Events
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:
2008-08
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 assess interactions between selected cardiovascular medications and genes in the incidence of heart attack stroke and atrial fibrillation an irregular heartbeat
Detailed Description:
BACKGROUND
This complex study will collect additional genetic data for 3 ongoing case-control observational studies of drug-gene interactions in myocardial infarction stroke and new-onset atrial fibrillation This study will add single nucleotide polymorphism SNP discovery for 16 of 36 candidate genes involving the renin-angiotensin system sodium transport adrenergic receptors and G-proteins and allow analysis of haplotype data
The study was initiated in response to RFA HL-03-001 Ancillary Studies in Pharmacogenetics
DESIGN NARRATIVE
The primary aim of this study is to assess interactions between selected cardiovascular medications and the major candidate-gene variants or haplotypes on the incidence of myocardial infarction MI stroke and atrial fibrillation AF The candidate-gene sets-selected on the basis of biology pharmacology and information from genome-wide scans-include 1 10 genes in the renin-angiotensin system 2 10 genes involved in renal sodium transport 3 8 genes encoding alpha and beta adrenergic receptors 4 8 other genes including G-proteins estrogen receptors and the alpha-1C subunit of the L-type calcium channel The products of these genes represent the sites of action for many cardiovascular drugs angiotensin-converting enzyme inhibitors angiotensin receptor blockers all classes of diuretics alpha blockers beta-blockers central alpha agonists calcium antagonists and estrogens Both hypothesis-testing and hypothesis-generating analyses are planned For selected single nucleotide polymorphisms SNPs studied in vitro or in small clinical populations several specific drug-gene interactions are plausible and these associations will be evaluated in an hypothesis-testing manner
The study used data from previously funded case-control studies which are expected to produce 1053 MI cases 565 stroke cases and 800 atrial fibrillation cases and 3249 matching controls from the enrollees of Group Health Cooperative These patients will already have had chart abstractions pharmacy database searches telephone interviews and phlebotomy with specimen storage
This complex study will collect additional genetic data for 3 ongoing case-control observational studies of drug-gene interactions in myocardial infarction stroke and new-onset atrial fibrillation This study will add single nucleotide polymorphism SNP discovery for 16 of 36 candidate genes involving the renin-angiotensin system sodium transport adrenergic receptors and G-proteins and allow analysis of haplotype data
The study was initiated in response to RFA HL-03-001 Ancillary Studies in Pharmacogenetics
DESIGN NARRATIVE
The primary aim of this study is to assess interactions between selected cardiovascular medications and the major candidate-gene variants or haplotypes on the incidence of myocardial infarction MI stroke and atrial fibrillation AF The candidate-gene sets-selected on the basis of biology pharmacology and information from genome-wide scans-include 1 10 genes in the renin-angiotensin system 2 10 genes involved in renal sodium transport 3 8 genes encoding alpha and beta adrenergic receptors 4 8 other genes including G-proteins estrogen receptors and the alpha-1C subunit of the L-type calcium channel The products of these genes represent the sites of action for many cardiovascular drugs angiotensin-converting enzyme inhibitors angiotensin receptor blockers all classes of diuretics alpha blockers beta-blockers central alpha agonists calcium antagonists and estrogens Both hypothesis-testing and hypothesis-generating analyses are planned For selected single nucleotide polymorphisms SNPs studied in vitro or in small clinical populations several specific drug-gene interactions are plausible and these associations will be evaluated in an hypothesis-testing manner
The study used data from previously funded case-control studies which are expected to produce 1053 MI cases 565 stroke cases and 800 atrial fibrillation cases and 3249 matching controls from the enrollees of Group Health Cooperative These patients will already have had chart abstractions pharmacy database searches telephone interviews and phlebotomy with specimen storage
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?: