Clinical Trial: Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: April 17, 2014
Date Started: December 2008
Date Completion: December 2017
Last Updated: January 12, 2017
Last Verified: January 2017