PFAST: Pediatric Foramen Ovale and Stroke in Sickle Cell Disease

Study ID
Study00000028

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Patricia Plumb
214-456-6761
patricia.plumb@childrens.com

Principal Investigator
Michael Dowling

Summary

There are two treatment arms: sickle cell disease with stroke and age within 2 years matched control. Both study groups will have transthoracic echocardiograms with agitated saline. The Sickle cell disease arm will have a simultaneous transcranial doppler at the time of the echocardiogram. The study endpoint is the end of the echocardiogram.

1/8/2013: We are no longer going to perform the TCD, transcranial doppler due to negative interim analysis results.

Participant Eligibility

Inclusion Criteria for Patients with SCD:

1. Children age 2-19 years with a diagnosis of SCD (incl. SS & S[BETA]0 thalassemia)
2. History of clinically overt ischemic stroke confirmed by CT, CTA or MRI.
(Stroke can be remote or acute)
3. Intravenous (IV) access obtained for another medical indication (e.g. blood
transfusion), hydration, or administration of IV medication.


Inclusion Criteria for Control Patients:

1. Children ages 2-19 without SCD or stroke
2. IV access obtained for another medical indication, such as blood transfusion,
hydration, or administration of IV medication.
3. No known history of overt stroke, known or suspected congenital heart disease, or
genetic syndrome predisposing to congenital heart disease (e.g. Downs Syndrome)
4. Not undergoing TTE for evaluation of Transient ischemic attack, migraine headache
or other neurologic indication for TTE. Children scheduled for clinical TTE with or
without contrast for other clinical indications such as rule out endocarditis, WILL be
eligible for inclusion.