Brain MRI Analysis for Congenital Heart Disease
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston Children's Hospital
Disqualifiers: Mental illness, Brain injury, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The main purpose of this proposal is to perform novel MRI analyses to determine the brain organizational changes associated with altered executive function and the modulating role of variants in neuroresilience and hypoxia response genes in adults with d-transposition of the great arteries (d-TGA).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment MRI for congenital heart disease?
MRI is effective in identifying brain abnormalities and assessing the severity of brain injury in newborns with congenital heart disease, which can help predict neurodevelopmental outcomes and guide treatment decisions.
12345Is MRI safe for people with congenital heart disease?
MRI is generally considered safe for people with congenital heart disease, but there can be some risks, especially in critically ill infants. Studies have looked at the safety of MRI, including the use of contrast agents, and found that while adverse events can occur, they are relatively rare.
16789How does this treatment differ from other treatments for congenital heart disease?
This treatment is unique because it uses advanced MRI techniques, like diffusion tensor imaging and apparent diffusion coefficient metrics, to analyze brain development in infants with congenital heart disease, providing more detailed and quantitative information about brain alterations compared to traditional methods.
24101112Eligibility Criteria
This trial is for adults with d-transposition of the great arteries who were part of past studies at Boston Children's Hospital, and healthy adults matching their age and sex. Participants must be able to consent to an MRI scan and some cognitive tests. People can't join if they have metal implants, claustrophobia, mental illness history, brain injuries or interventions, intellectual impairments that prevent questionnaire completion, or are not fluent in English.Inclusion Criteria
I am a healthy adult who can consent to an MRI and some brain function tests.
You were part of a previous study at Boston Children's Hospital when you were a child.
Exclusion Criteria
I cannot complete study forms by myself due to intellectual impairment.
You cannot speak and read English well.
You cannot have an MRI if you have metal in your body, feel very scared in small spaces, have had mental health issues, brain injury, or brain surgery before.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
MRI Assessment
Participants undergo advanced multimodal brain MRI to assess sulcal patterns, structural and functional connectivity
1-2 weeks
1 visit (in-person)
Genetic Analysis
Genetic analysis to identify presence of neuroresilience gene ApoE ε2 or ε4 alleles and hypoxia response gene variants
2 weeks
Follow-up
Participants are monitored for cognitive outcomes using the Delis-Kaplan Executive Function Scale (D-KEFS)
4 weeks
Participant Groups
The study uses advanced MRI scans to explore how certain heart defects from birth affect the brain's structure and function related to decision-making skills. It also looks into how genetic differences might influence these changes.
1Treatment groups
Experimental Treatment
Group I: Brain MRIExperimental Treatment1 Intervention
Obtain Brain MRI in adults with congenital heart disease and age/sex matched controls
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
References
Preventing brain injury in newborns with congenital heart disease: brain imaging and innovative trial designs. [2019]Newborns with congenital heart disease are at high risk for brain injury and adverse neurodevelopmental outcomes. MRI enables the objective determination of the severity of brain injury in critically ill newborns with congenital heart disease. We will rationalize the use of MRI as a surrogate for neurodevelopmental outcome and describe novel randomization techniques that can be used in trials in this population.
Regional alterations in cerebral growth exist preoperatively in infants with congenital heart disease. [2021]Magnetic resonance imaging has been used to define the neurologic abnormalities in infants with congenital heart disease (CHD), including preoperative injury and delayed brain maturation. The present study used qualitative scoring, cerebral biometry, and diffusion imaging to characterize the preoperative brain abnormalities in infants with CHD, including the identification of regions of greater vulnerability.
A Uniform Description of Perioperative Brain MRI Findings in Infants with Severe Congenital Heart Disease: Results of a European Collaboration. [2022]A uniform description of brain MR imaging findings in infants with severe congenital heart disease to assess risk factors, predict outcome, and compare centers is lacking. Our objective was to uniformly describe the spectrum of perioperative brain MR imaging findings in infants with congenital heart disease.
Impaired neuroanatomic development in infants with congenital heart disease. [2009]We performed a regional volumetric study of the brain using 3-dimensional magnetic resonance imaging in infants with congenital heart disease to search for variables in anatomic development of the brain that may be associated with functional impairment.
Association of Isolated Congenital Heart Disease with Fetal Brain Maturation. [2021]Brain MRI of newborns with congenital heart disease show signs of immaturity relative to healthy controls. Our aim was to determine whether the semiquantitative fetal total maturation score can detect abnormalities in brain maturation in fetuses with congenital heart disease in the second and third trimesters.
Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]To assess the incidence and severity of adverse events (AE) associated with cardiovascular magnetic resonance (CMR) in a large cohort of patients with congenital heart disease and to identify independent risk factors for their occurrence.
Cardiovascular magnetic resonance imaging for intensive care infants: safe and effective? [2021]Cardiac magnetic resonance imaging (MRI) is an important diagnostic tool for congenital heart disease (CHD), as reflected by class 1 recommendations for the use of cardiac MRI by various consensus panels. However, little is known about the safety and clinical utility of cardiac MRI for these critically ill infants with CHD, whose further management cannot be directed by echocardiography. This study aimed to assess the safety, the potential hemodynamic side effects, and the clinical benefits of cardiac MRI for infants with complex CHD during their intensive care unit stay.
Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging.
Feasibility of ferumoxytol-enhanced neonatal and young infant cardiac MRI without general anesthesia. [2018]To assess the feasibility of ferumoxytol-enhanced anesthesia-free cardiac MRI in neonates and young infants for complex congenital heart disease (CHD).
Brain tissue development of neonates with Congenital Septal Defect: Study on MRI Image Evaluation of Deep Learning Algorithm. [2022]This article is based on deep learning algorithms and uses MRI to study the development of congenital heart septal defects in neonatal brain tissue.
White matter injury in newborns with congenital heart disease: a diffusion tensor imaging study. [2021]Brain injury is observed on cranial magnetic resonance imaging preoperatively in up to 50% of newborns with congenital heart disease. Newer imaging techniques such as diffusion tensor imaging provide sensitive measures of the white matter integrity. The objective of this study was to evaluate the diffusion tensor imaging analysis technique of tract-based spatial statistics in newborns with congenital heart disease.
Multi-Slice Radiomic Analysis of Apparent Diffusion Coefficient Metrics Improves Evaluation of Brain Alterations in Neonates With Congenital Heart Diseases. [2020]Apparent diffusion coefficients (ADC) can provide phenotypic information of brain lesions, which can aid the diagnosis of brain alterations in neonates with congenital heart diseases (CHDs). However, the corresponding clinical significance of quantitative descriptors of brain tissue remains to be elucidated. By using ADC metrics and texture features, this study aimed to investigate the diagnostic value of single-slice and multi-slice measurements for assessing brain alterations in neonates with CHDs. ADC images were acquired from 60 neonates with echocardiographically confirmed non-cyanotic CHDs and 22 healthy controls (HCs) treated at Children's Hospital of Nanjing Medical University from 2012 to 2016. ADC metrics and texture features for both single and multiple slices of the whole brain were extracted and analyzed to the gestational age. The diagnostic performance of ADC metrics for CHDs was evaluated by using analysis of covariance and receiver operating characteristic. For both the CHD and HC groups, ADC metrics were inversely correlated with the gestational age in single and multi-slice measurements (P < 0.05). Histogram metrics were significant for identifying CHDs (P < 0.05), while textural features were insignificant. Multi-slice ADC (P < 0.01) exhibited greater diagnostic performance for CHDs than single-slice ADC (P < 0.05). These findings indicate that radiomic analysis based on ADC metrics can objectively provide more quantitative information regarding brain development in neonates with CHDs. ADC metrics for the whole brain may be more clinically significant in identifying atypical brain development in these patients. Of note, these results suggest that multi-slice ADC can achieve better diagnostic performance for CHD than single-slice.