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

Cerebrovascular Accident Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037388
• Other study ID #: 1167
• Secondary ID: R01HL069114
• Status: Completed
• Phase: N/A
• First received: May 16, 2002
• Last updated: July 28, 2016
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: January 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Blood Disease
• Cerebrovascular Accident
• Chlamydia Infections
• Hematologic Diseases
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)