Cerebrovascular Accident Clinical Trial
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.
;
Time Perspective: Retrospective
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