Overview

This trial is active, not recruiting.

Condition single ventricle defect
Sponsor Children's Hospital of Philadelphia
Collaborator National Institutes of Health (NIH)
Start date December 2008
End date June 2015
Trial size 260 participants
Trial identifier NCT02135081, 08-006166, 1R01HL090615-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
Cerebral blood flow changes throughout staged surgical reconstruction in single ventricle patients.
time frame: Up to 2 years

Secondary Outcomes

Measure
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
CBF reserve after Stage 1 compared with CBF reserve in hemi Fontan/bidirectional Glenn stage of surgeries.
time frame: Up to 2 years

Eligibility Criteria

Male or female participants from 4 months up to 10 years old.

Inclusion Criteria - Single Ventricle Subjects: - Males or females up to age 10 years. - Any complex congenital heart lesion that has single ventricle physiology. These single ventricle lesions will be of either right or left ventricular morphology. - Ability to undergo an MRI scan of at least 60-90 minutes under general anesthesia or deep sedation. Patients will undergo determination of their physical ability to undergo the MRI prior to being enrolled in the study by parameters such as blood pressure, heart rate, cardiac rhythm, and respiratory rate. MRI involves laying still in the supine position for at least 60-90 minutes. - Parents signing informed consent. Inclusion Criteria - Normal Control Group: - Males or females up to age 10 years. - Normal cerebral anatomy who are normocephalic and who are asymptomatic (e.g. if the scan is performed for headache) at the time of the scan. - Ability to undergo an MRI scan of at least 60-90 minutes under general anesthesia or deep sedation. Normal patients will undergo determination of their physical ability to undergo the MRI prior to being enrolled in the study by parameters such as blood pressure, heart rate, cardiac rhythm, and respiratory rate. MRI involves laying still in the supine position for at least 60-90 minutes. - Parents signing informed consent. Exclusion Criteria - Single Ventricle Patients : - Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient. - Stenosis of the branch pulmonary arteries or coarctation of the aorta. - Any significant arrhythmias such as supraventricular tachycardia, trigeminy, etc. Occasional premature atrial or ventricular contractions or an occasional missed beat is permitted. - Systemic hypertension. - Primary lung disease (eg bronchopulmonary dysplasia). - Any known significant neurological disease outside of the usual state of single ventricle patients. - Any chromosomal anomalies or other major anomalies which would confound neurological outcome. - A patient with a pacemaker or cardioverter/defibrillator in place. - A ferromagnetic foreign body (with the exception of sternal wires and vascular clips in the thorax). - Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Exclusion Criteria - Normal Control Group: - Any condition judged by the patient's physician that would cause this trial to be detrimental to the patient. - Any known significant neurological disease - Any contraindication to performing an MRI. - Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Additional Information

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
Principal investigator Mark Fogel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.