CTEH: Cancer Therapy Effects on the Heart
Study Details
Study Description
Brief Summary
Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.
Cardiac remodeling, function, and tissue characteristics will be examined using cardiac MRI data in combination with standard cardiac assessments (by echocardiography, electrocardiograms, and cardiac MRI) to assess the cardiotoxic effects of cancer therapy. Analyses will be performed in a cohort of adolescents and young adults with a history of childhood cancer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All Study Participants This is an observational study where all study participants are within a single group. |
Diagnostic Test: Cardiac magnetic resonance imaging (MRI)
Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
Diagnostic Test: Echocardiography
Echocardiography, heart ultrasound, will be performed in conjunction with cardiac MRI.
Diagnostic Test: Electrocardiogram
Measuring conduction abnormalities
|
Outcome Measures
Primary Outcome Measures
- Left ventricular ejection fraction (LVEF) [5 years]
LVEF is an assessment of left ventricular global systolic function.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
English and Spanish speaking male and female subjects, ages 13-39 years old
-
Diagnosis of cancer at age <22 years
-
Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior.
Exclusion Criteria:
-
Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants.
-
Medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia.
-
Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus).
-
Patients with orthodontic braces or metallic implants in the thorax or abdomen/lumbar spine, even if MRI-compatible, will be excluded as these may cause artifacts and limit image quality.
-
Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rady Children's Hospital | San Diego | California | United States | 92123 |
Sponsors and Collaborators
- Hari Narayan
Investigators
- Principal Investigator: Hari Narayan, MD, University of California San Diego, Rady Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 181758