Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006496
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2000-11-16
Brief Title:
Molecular Epidemiology of ARDS
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Molecular Epidemiology of Acute Respiratory Distress Syndrome
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 examine the possible relationship between genetic factors and the acute respiratory distress syndrome ARDS
Detailed Description:
BACKGROUND
The acute respiratory distress syndrome ARDS remains a major cause of morbidity and mortality around the world In the United States alone there are 150000 cases per year Although there have been significant scientific advances in understanding the clinical and pathophysical aspects of the syndrome there is as yet no specific therapy for ARDS Moreover although major risk factors for the development of ARDS include sepsis aspiration and multiple trauma only a minority of patients with these risk factors develop ARDS Individual differences in susceptibility to chronic disease have been a subject of active molecular epidemiologic investigations for the past decade In particular risk factors for cancer conferred by heritable polymorphisms and various metabolic functions have been reported More recently a polymorphism of endothelial nitrate oxide synthase has been associated with an increased susceptibility to coronary-artery disease and polymorphisms in GSTM1 have been associated with an increased risk of developing asbestosis A recent study of tumor necrosis factor TNF polymorphisms has been associated with poor outcome in ARDS
DESIGN NARRATIVE
The case-control study examined the association between specific polymorphisms in several genes coding for specific inflammatory responses and for surfactant protein and their potential association with increased susceptibility to ARDS The first objective was to assess the role of candidate-gene polymorphisms as risk factors for ARDS in a case-control study The second objective was to assess the relationship between genotype and phenotype for candidate markers in cases and controls The third objective was to assess the role of these polymorphisms in clinical outcome survival recovery using patients from both the proposed case-control study and the multicenter case series and clinical trial sponsored by the NHLBI ARDS network By combining both a large case-control study and case series from the network the study had the advantages of sufficient case ascertainment statistical power diagnostic standardization uniform outcome criteria and study efficiency Overall the results of this study should provide new insights into the epidemiology of ARDS and allow for possible preventive strategies as well as possible modifications of therapeutic interventions for the Network Phase III trials
The investigators test the hypothesis that there is an increased risk of ARDS in patients with heritable traits relating to inflammatory cytokines and surfactant They are examining risk and prognosis and examining case and control genetics in relation to cytokine levels They also plan to do a case-series analysis from a separate study of the ARDS network They will examine TNF alpha and beta interleukin-1 receptor antagonist surfactant protein B and interleukin-10 IL-10
The acute respiratory distress syndrome ARDS remains a major cause of morbidity and mortality around the world In the United States alone there are 150000 cases per year Although there have been significant scientific advances in understanding the clinical and pathophysical aspects of the syndrome there is as yet no specific therapy for ARDS Moreover although major risk factors for the development of ARDS include sepsis aspiration and multiple trauma only a minority of patients with these risk factors develop ARDS Individual differences in susceptibility to chronic disease have been a subject of active molecular epidemiologic investigations for the past decade In particular risk factors for cancer conferred by heritable polymorphisms and various metabolic functions have been reported More recently a polymorphism of endothelial nitrate oxide synthase has been associated with an increased susceptibility to coronary-artery disease and polymorphisms in GSTM1 have been associated with an increased risk of developing asbestosis A recent study of tumor necrosis factor TNF polymorphisms has been associated with poor outcome in ARDS
DESIGN NARRATIVE
The case-control study examined the association between specific polymorphisms in several genes coding for specific inflammatory responses and for surfactant protein and their potential association with increased susceptibility to ARDS The first objective was to assess the role of candidate-gene polymorphisms as risk factors for ARDS in a case-control study The second objective was to assess the relationship between genotype and phenotype for candidate markers in cases and controls The third objective was to assess the role of these polymorphisms in clinical outcome survival recovery using patients from both the proposed case-control study and the multicenter case series and clinical trial sponsored by the NHLBI ARDS network By combining both a large case-control study and case series from the network the study had the advantages of sufficient case ascertainment statistical power diagnostic standardization uniform outcome criteria and study efficiency Overall the results of this study should provide new insights into the epidemiology of ARDS and allow for possible preventive strategies as well as possible modifications of therapeutic interventions for the Network Phase III trials
The investigators test the hypothesis that there is an increased risk of ARDS in patients with heritable traits relating to inflammatory cytokines and surfactant They are examining risk and prognosis and examining case and control genetics in relation to cytokine levels They also plan to do a case-series analysis from a separate study of the ARDS network They will examine TNF alpha and beta interleukin-1 receptor antagonist surfactant protein B and interleukin-10 IL-10
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 |
|---|---|---|---|
| R01HL060710 | NIH | None | httpsreporternihgovquickSearchR01HL060710 |