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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00037388
First received: May 16, 2002
Last updated: January 18, 2008
Last verified: January 2008

May 16, 2002
January 18, 2008
July 2004
June 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00037388 on ClinicalTrials.gov Archive Site
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Pediatrics:Chlamydia, Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II
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To establish a link among Chlamydia infection, sickle cell anemia, and stroke risk.

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.

Observational
Time Perspective: Retrospective
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  • Blood Disease
  • Anemia, Sickle Cell
  • Chlamydia Infections
  • Cerebrovascular Accident
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2006
June 2006   (final data collection date for primary outcome measure)

No eligibility criteria

Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00037388
1167
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Lori Styles Children's Hospital & Research Center Oakland
National Heart, Lung, and Blood Institute (NHLBI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP