Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037388
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2002-05-16
Brief Title:
PediatricsChlamydia Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II
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:
2008-01
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 establish a link among Chlamydia infection sickle cell anemia and stroke risk
Detailed Description:
BACKGROUND
Infection with Chlamydia pneumoniae C pneumoniae is associated with an increased risk of cerebrovascular disease in the general population Children with sickle cell anemia SCA are 200 times more likely to have cerebrovascular disease than normal children and are known to have an altered immune response to many infectious pathogens C pneumoniae is the leading infectious cause of acute chest syndrome which interestingly is a well- established risk factor for stroke in children with SCA Preliminary data indicates that SCA patients with magnetic resonance imaging MRI-documented cerebral infarction are 12 times more likely to have C pneumoniae infection than SCA patients with normal MRI scans The investigators hypothesize that SCA patients have an abnormal immune response to C pneumoniae that results in persistent infection which in turn triggers the development of cerebrovascular disease Sickle cell anemia patients with an elevated velocity on transcranial doppler ultrasound TCD are known to be at high risk to develop stroke and an elevated TCD likely reflects underlying vascular disease In addition the Stroke Prevention in Sickle Cell Anemia Trial STOP demonstrated that almost 40 percent of children with an elevated TCD have evidence of cerebral infarction on MRI Children with abnormal TCDs are therefore an appropriate population to investigate an association between cerebrovascular disease and C pneumoniae infection
The study is in response to an initiative on Ancillary Studies in Heart Lung and Blood Disease Trials released in June 2000
DESIGN NARRATIVE
The study is ancillary to the STOP II clinical trial The intent is 1 To determine if C pneumoniae infection is associated with cerebral infarction in children with SCA 2 To characterize the immunological response to C pneumoniae infection in patients with SCA Establishing a link between Cpneumoniae infection and cerebral infarction will open the door to novel less toxic approaches to the treatment and prevention of stroke in SCA including antibiotics and vaccines
Infection with Chlamydia pneumoniae C pneumoniae is associated with an increased risk of cerebrovascular disease in the general population Children with sickle cell anemia SCA are 200 times more likely to have cerebrovascular disease than normal children and are known to have an altered immune response to many infectious pathogens C pneumoniae is the leading infectious cause of acute chest syndrome which interestingly is a well- established risk factor for stroke in children with SCA Preliminary data indicates that SCA patients with magnetic resonance imaging MRI-documented cerebral infarction are 12 times more likely to have C pneumoniae infection than SCA patients with normal MRI scans The investigators hypothesize that SCA patients have an abnormal immune response to C pneumoniae that results in persistent infection which in turn triggers the development of cerebrovascular disease Sickle cell anemia patients with an elevated velocity on transcranial doppler ultrasound TCD are known to be at high risk to develop stroke and an elevated TCD likely reflects underlying vascular disease In addition the Stroke Prevention in Sickle Cell Anemia Trial STOP demonstrated that almost 40 percent of children with an elevated TCD have evidence of cerebral infarction on MRI Children with abnormal TCDs are therefore an appropriate population to investigate an association between cerebrovascular disease and C pneumoniae infection
The study is in response to an initiative on Ancillary Studies in Heart Lung and Blood Disease Trials released in June 2000
DESIGN NARRATIVE
The study is ancillary to the STOP II clinical trial The intent is 1 To determine if C pneumoniae infection is associated with cerebral infarction in children with SCA 2 To characterize the immunological response to C pneumoniae infection in patients with SCA Establishing a link between Cpneumoniae infection and cerebral infarction will open the door to novel less toxic approaches to the treatment and prevention of stroke in SCA including antibiotics and vaccines
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 |
|---|---|---|---|
| R01HL069114 | NIH | None | httpsreporternihgovquickSearchR01HL069114 |