Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction (CBF)
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|ClinicalTrials.gov Identifier: NCT02135081|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : March 19, 2018
|Condition or disease|
|Single Ventricle Defect|
|Study Type :||Observational|
|Actual Enrollment :||260 participants|
|Official Title:||A Magnetic Resonance Imaging Study to Determine Cerebral Blood Flow Changes in Single Ventricle Patients During Staged Reconstruction as Compared to Normal Children|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||November 2016|
Subjects will be single ventricle patients who will be prospectively recruited when they are at the first stage of Fontan reconstruction; they will be followed throughout all 3 stages with cerebral blood flow measurements and brain MRIs.
Additional single ventricle patients who will not participate in the study for all 3 stages but who may participate for one of two. For example, patients who completed their Stage I and hemi Fontan/bidirectional Glenn operations before this study began will be recruited before Fontan stage completion. Also, patients whose Stage I and hemi Fontan/bidirectional Glenn surgeries will be completed during the study, but who will not complete all 3 surgical stages before this project ends. Cerebral blood flow measurements and brain MRIs will be completed after each surgical stage which occurs during study participation.
Normal Control Group
Children likely to have a normal brain MRI will be asked to participate. After the brain MRI is obtained as part of routine clinical care, and a normal brain scan is confirmed, measurement of cerebral blood flow using velocity mapping in the jugular veins and the aorta will be performed. This will add approximately 10 minutes to the scan but no extra sedation medications will be administered to obtain this data.
- Cerebral blood flow changes throughout staged surgical reconstruction in single ventricle patients. [ Time Frame: Up to 2 years ]Cerebral blood flow & systemic blood flow will be measured via MRI in addition to cerebral anatomy and volume at all 3 stages.
- CBF in single ventricle patients compared to CBF of age-matched normal children. [ Time Frame: Up to 2 years ]
- CBF reserve and "intactness" of the cerebral regulatory mechanisms after Stage I and hemi Fontan/bidirectional Glenn stage of surgeries. [ Time Frame: Up to 2 years ]Determine CBF reserve and "intactness" of the cerebral regulatory mechanisms in patients after Stage I and hemi Fontan/bidirectional Glenn stage of surgeries by obtaining CBF under normal conditions and under conditions of hypercarbia prior to surgery.
- CBF reserve after Stage 1 compared with CBF reserve in hemi Fontan/bidirectional Glenn stage of surgeries. [ Time Frame: Up to 2 years ]
- Age related CBF changes between 4-6 months to 3-10 years. [ Time Frame: Up to 2 hours ]Determine age related CBF changes in a group of normal children from ages 4-6 months to 3-10 years undergoing clinical brain MRIs for other reasons and found not to have pathology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135081
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Mark Fogel, MD||CHOP Physician|