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Search Results Within Category "Cardiology/Heart"

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35 Study Matches

A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma

This study assesses how blood cell growth patterns (clonal hematopoiesis) relate to heart health or cardiovascular disease (CVD) after treatment in patients with Hodgkin lymphoma. In some patients, cancer treatment at a young age may lead to later complications, including problems with heart health. Checking for blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) can help predict who might be at risk for heart health problems after Hodgkin lymphoma treatment. If doctors know who may be at greater risk for developing later heart complications, then they can more closely monitor those patients to prevent or detect heart complications early.

- cancer@cchmc.org

ALL
7 years and over
This study is NOT accepting healthy volunteers
NCT05705531
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Inclusion Criteria:
* Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation). * History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \>= 2 and \< 22 years of age. * As part of frontline therapy for cHL, the patient must have received a cumulative doxorubicin equivalent anthracycline dose of ≥ 200 mg/m\^2 as estimated in doxorubicin isotoxic equivalents dose conversion calculation. * Note: History of COG therapeutic trial participation is not required. Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used as reference documentation of receipt of anthracycline dose. * All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment. * Not known to have had a primary event (relapse/second malignancy/death). * Note: Subjects treated at another institution are eligible if they are now being followed at the current COG institution, if the study procedures can be performed and the data accessible by a COG institution where the study is open. * Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation.
Exclusion Criteria:
* Medical contraindication to undergoing a non-contrast cardiac MRI. * Patients with nodular lymphocyte-predominant HL. * Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm). * History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL. * Note: exceptions are made for congenital conditions considered fully resolved by surgery and chronic conditions such as hypertension or hypercholesterolemia that are managed with medical intervention. * History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents.
PROCEDURE: Archive Sample Retrieval, PROCEDURE: Biospecimen Collection, OTHER: Electronic Health Record Review, PROCEDURE: Magnetic Resonance Imaging, OTHER: Survey Administration
Cardiovascular Disorder, Classic Hodgkin Lymphoma, Clonal Hematopoiesis
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HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis (HeartGPS)

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

- heartgps@cchmc.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT06175104
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Inclusion Criteria
• Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
• Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
• Singleton pregnancy.
• Pregnant person is planning to continue with the pregnancy.
• Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria
• Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
• Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
• Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
• Parent with a moderate to severe intellectual disability.
• Parent age \<18 years.
• Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
BEHAVIORAL: HeartGPS
Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological, Neurodevelopmental Disorders
Congenital Heart Disease, Prenatal, Mental Health, Neurodevelopment, Neurobehavior, Fetal Cardiology, Psychological Intervention, Mother-Infant Attachment, Mother-Infant Bonding, Medical Traumatic Stress, Neuroimaging, Brain Development, Fetal Neuroimaging, Perinatal Mental Health, Medical Psychology
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Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders (HIBR-ACHD)

A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.

Olivia Croweak - olivia.croweak@cchmc.org

ALL
16 years and over
This study is also accepting healthy volunteers
NCT07477197
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Inclusion Criteria:

• Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
• Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
• A family member or other person accompanying a patient to a clinical encounter; or,
• A volunteer recruited via an advertisement; or,
• Another person who volunteers to enroll in HIBR-ACHD.
• A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
Exclusion Criteria:
* Unable to provide informed consent/assent personally or via a legal guardian. * Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator. * Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days.
Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
ACHD, Adult Congenital Heart Disease
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Heart Institute BioRepository (HIBR) for Pediatric Heart Disease (HIBR)

The purpose of this protocol is to redefine the Heart Institute BioRepository (HIBR) to facilitate Investigator-initiated and programmatic basic, translational, clinical and outcomes research. For the purposes of this protocol, "tissue" will refer to any gross specimen obtained from a patient, including but not limited to blood, cardiovascular tissue, urine, saliva, and other tissues and bodily fluids, including explanted non-human prosthetics or grafts. In this context, "tissue" is synonymous with "sample" or "specimen." A "BioRepository" functions to systematically collect, maintain and govern tissue specimens.

Olivia Croweak - olivia.croweak@cchmc.org

ALL
This study is NOT accepting healthy volunteers
NCT07478354
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Inclusion Criteria * Any fetus, child or adult at risk of or diagnosed with Pediatric Heart Disease (PHD) or Cardiovascular Disease (CVD) * Any HI patient, including the following types of encounters: Surgery or Cardiac Catheterization or Advanced Imaging encounters, Inpatient, including Cardiology service, consultation patients and Fetal Delivery, and Outpatient, including all HI-associated clinics and consultation services * Any female carrying a fetus with a suspected cardiac diagnosis Exclusion Criteria * Legal guardian unauthorized to consent * Families who choose Palliative care during pregnancy
Cardiovascular Diseases (CVD)
cardiovascular disease, Pediatric Heart disease
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BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease

The primary objective of this study is to enhance the rates of direct breast feeding (DBF) among infants with congenital heart disease (CHD), and to gain insights into the implications of DBF on key metrics of child and parent well-being. A multicenter parallel cluster platform design will be employed. The intervention will be a multifaceted approach to enhance direct breastfeeding. Participating sites will be randomized into either intervention (strategies to enhance direct breastfeeding) or conventional care.

- olivia.cleary@cchmc.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT07582848
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Both mothers and infants are study participants. Inclusion criteria:
• Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
• Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
• Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.
• Willing to comply with protocol and provide written informed consent
Exclusion Criteria:

• Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
• Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
• Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
• Infant birthweight \<3rd percentile for gestational age
• Infant gestational age \< 36 weeks
• Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
• Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator
OTHER: Breastfeeding clinical practice guideline (CPG) for congenital heart disease (CHD)
Congenital Heart Disease (CHD)
Direct breastfeeding, CHD, Infant neurodevelopment, Maternal Mental Health
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