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

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00037388
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 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.

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Retrospective
    Study Start Date :
    Jul 1, 2004
    Actual Primary Completion Date :
    Jun 1, 2006
    Actual Study Completion Date :
    Jun 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 100 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      No eligibility criteria

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      • : Lori Styles, UCSF Benioff Children's Hospital Oakland

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00037388
      Other Study ID Numbers:
      • 1167
      • R01HL069114
      First Posted:
      May 17, 2002
      Last Update Posted:
      Jul 29, 2016
      Last Verified:
      Jan 1, 2008

      Study Results

      No Results Posted as of Jul 29, 2016