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Pediatrics:Chlamydia, Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II - Article


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Blood Gases


Clinical Trial: Pediatrics:Chlamydia, Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II

This study is no longer recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To establish a link among Chlamydia infection, sickle cell anemia, and stroke risk.

Condition
Blood Disease
Anemia, Sickle Cell
Chlamydia Infections
Cerebrovascular Accident

MedlinePlus related topics:  Blood and Blood Disorders;   Chlamydia Infections;   Sickle Cell Anemia;   Stroke
Genetics Home Reference related topics:  sickle cell anemia

Study Type: Observational
Study Design: Defined Population, Retrospective Study

Further Study Details: 

Study start: September 2001;  Study completion: June 2005

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 C.pneumoniae 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.

Eligibility

Genders Eligible for Study:  Both

Criteria

No eligibility criteria

Location Information

Study chairs or principal investigators

Lori Styles,  Children's Hospital, Oakland   

More Information

Study ID Numbers:  1167
Record last reviewed:  December 2004
Last Updated:  January 10, 2005
Record first received:  May 16, 2002
ClinicalTrials.gov Identifier:  NCT00037388
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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