Single Ventricle DefectCBFNCT02135081
Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction
An observational study of Single Ventricle Defect, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 months to 10 years
- Conditions the study is for
- Single Ventricle Defect
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Single ventricle patients will be recruited from the cohort of patients treated and/or followed at The Children's Hospital of Philadelphia in the cardiology program and surrounding hospitals/institutions. In specific, patients will be approached to participate in the study during clinic visits or visits to the hospital for other reasons. Children for the normal control group will be recruited from children who are undergoing clinical MRIs at CHOP. A full understanding of all study related procedures and processes will be explained to the subject, including all MRI scans, how the MRI scanner works and how the proposed research will help medical practice. Children likely to have a normal brain MRI will be asked to participate and sign an informed consent form.
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the 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.
- Conditions
- Single Ventricle Defect
- Keywords
- Single ventricle, Hypoplastic Left Heart Syndrome, Congenital heart lesion, Right or left ventricle, Cerebral blood flow, Pulmonary blood flow, Staged Fontan reconstruction, hemi Fontan/bidirectional Glenn stages
- Medical subject headings
- Univentricular Heart, Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Ventricle | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow changes throughout staged surgical reconstruction in single ventricle patients.
Cerebral blood flow \& systemic blood flow will be measured via MRI in addition to cerebral anatomy and volume at all 3 stages.
Measured: Up to 2 years
Secondary outcomes (3)
CBF in single ventricle patients compared to CBF of age-matched normal children.
Measured: Up to 2 years
CBF reserve and "intactness" of the cerebral regulatory mechanisms after Stage I and hemi Fontan/bidirectional Glenn stage of surgeries.
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.
Measured: Up to 2 years
CBF reserve after Stage 1 compared with CBF reserve in hemi Fontan/bidirectional Glenn stage of surgeries.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startDec 2008
- Primary completionJun 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Single Ventricle DefectStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mark Fogel, MD, Principal investigator, CHOP Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135081
- Sponsor's protocol ID
- 08-006166
- Other IDs
- 1R01HL090615-01A1
- Acronym
- CBF
- Status last verified
- Mar 2018
- First submitted
- 17 Apr 2014
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fogel MA, Donnelly E, Crandell I, Hanlon A, Whitehead KK, Harris M, Partington S, Biko D, Flynn T, Nicolson S, Gaynor JW, Licht D, Vossough A. Cerebral Blood Flow, Brain Injury, and Aortic-Pulmonary Collateral Flow After the Fontan Operation. Am J Cardiol. 2023 Dec 1;208:164-170. doi: 10.1016/j.amjcard.2023.08.023. Epub 2023 Oct 14.
PubMed 37844519Fogel MA, Li C, Elci OU, Pawlowski T, Schwab PJ, Wilson F, Nicolson SC, Montenegro LM, Diaz L, Spray TL, Gaynor JW, Fuller S, Mascio C, Keller MS, Harris MA, Whitehead KK, Bethel J, Vossough A, Licht DJ. Neurological Injury and Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction. Circulation. 2017 Feb 14;135(7):671-682. doi: 10.1161/CIRCULATIONAHA.116.021724. Epub 2016 Dec 28.
PubMed 28031423Fogel MA, Li C, Wilson F, Pawlowski T, Nicolson SC, Montenegro LM, Diaz Berenstein L, Spray TL, Gaynor JW, Fuller S, Keller MS, Harris MA, Whitehead KK, Clancy R, Elci O, Bethel J, Vossough A, Licht DJ. Relationship of cerebral blood flow to aortic-to-pulmonary collateral/shunt flow in single ventricles. Heart. 2015 Aug;101(16):1325-31. doi: 10.1136/heartjnl-2014-307311. Epub 2015 Jun 5.
PubMed 26048877
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02135081
- Acronym / sponsor ID
- CBF / 08-006166
- Conditions
- Single Ventricle Defect
- Keywords
- Single ventricle, Hypoplastic Left Heart Syndrome, Congenital heart lesion, Right or left ventricle, Cerebral blood flow, Pulmonary blood flow, Staged Fontan reconstruction, hemi Fontan/bidirectional Glenn stages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ventricle | – | –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. |
Who may qualify
- Ages
- 4 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Single ventricle patients will be recruited from the cohort of patients treated and/or followed at The Children's Hospital of Philadelphia in the cardiology program and surrounding hospitals/institutions. In specific, patients will be approached to participate in the study during clinic visits or visits to the hospital for other reasons. Children for the normal control group will be recruited from children who are undergoing clinical MRIs at CHOP. A full understanding of all study related procedures and processes will be explained to the subject, including all MRI scans, how the MRI scanner works and how the proposed research will help medical practice. Children likely to have a normal brain MRI will be asked to participate and sign an informed consent form.
Key inclusion criteria (8 listed)
- 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.
- Males or females up to age 10 years.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Derived from this study: PubMed 37844519Fogel MA, Donnelly E, Crandell I, Hanlon A, Whitehead KK, Harris M, Partington S, Biko D, Flynn T, Nicolson S, Gaynor JW, Licht D, Vossough A. Cerebral Blood Flow, Brain Injury, and Aortic-Pulmonary Collateral Flow After the Fontan Operation. Am J Cardiol. 2023 Dec 1;208:164-170. doi: 10.1016/j.amjcard.2023.08.023. Epub 2023 Oct 14.
- Derived from this study: PubMed 28031423Fogel MA, Li C, Elci OU, Pawlowski T, Schwab PJ, Wilson F, Nicolson SC, Montenegro LM, Diaz L, Spray TL, Gaynor JW, Fuller S, Mascio C, Keller MS, Harris MA, Whitehead KK, Bethel J, Vossough A, Licht DJ. Neurological Injury and Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction. Circulation. 2017 Feb 14;135(7):671-682. doi: 10.1161/CIRCULATIONAHA.116.021724. Epub 2016 Dec 28.
- Derived from this study: PubMed 26048877Fogel MA, Li C, Wilson F, Pawlowski T, Nicolson SC, Montenegro LM, Diaz Berenstein L, Spray TL, Gaynor JW, Fuller S, Keller MS, Harris MA, Whitehead KK, Clancy R, Elci O, Bethel J, Vossough A, Licht DJ. Relationship of cerebral blood flow to aortic-to-pulmonary collateral/shunt flow in single ventricles. Heart. 2015 Aug;101(16):1325-31. doi: 10.1136/heartjnl-2014-307311. Epub 2015 Jun 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fogel, MD principal investigator
CHOP Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Ventricle Defect, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow changes throughout staged surgical reconstruction in single ventricle patients. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.