A Magnetic Resonance Imaging Study to Determine Cerebral Blood Flow Changes in Single Ventricle Patients During Staged Reconstruction as Compared to Normal Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Single Ventricle Defect
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Cerebral blood flow changes throughout staged surgical reconstruction in single ventricle patients.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study seeks to determine cerebral blood flow changes in single ventricle patients during staged surgical reconstruction as compared with normal children. Two general groups of single ventricle patients will be recruited for this study, corresponding to the two approaches used. An aged-match group of healthy subjects will be included as a control.
Detailed Description
This is a prospective, non-randomized, single center study designed to measure and determine the changes in cerebral blood flow in a cohort of single ventricle patients followed across all three stages of surgical (Fontan) reconstruction. In addition, cerebral blood flow response to hypercarbia will be determined after the first 2 operations as a measure of cerebral blood flow reserve and the "intactness" of the cerebral autoregulatory system. MRI data from this cohort will be compared with that collected in age-matched healthy children and in a cross sectional group of patients who will not necessarily be followed through all stages of surgery, but may undergo one or two of the MRI evaluations depending on their stage of surgery. Neurological exams and EEGs will be performed. Medical history, cardiac catheterization data, where available, will also be collected. Factors such as cardiopulmonary bypass time and socioeconomic class will be controlled for.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- CBF in single ventricle patients compared to CBF of age-matched normal children.(Up to 2 years)
- CBF reserve after Stage 1 compared with CBF reserve in hemi Fontan/bidirectional Glenn stage of surgeries.(Up to 2 years)
- CBF reserve and "intactness" of the cerebral regulatory mechanisms after Stage I and hemi Fontan/bidirectional Glenn stage of surgeries.(Up to 2 years)