Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to A… (NCT01671696) | Clinical Trial Compass
CompletedNot Applicable
Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy
United States80 participantsStarted 2011-11-15
Plain-language summary
The main hypothesis being tested is that magnetic resonance imaging and serologic biomarkers of apoptosis and extracellular matrix remodeling will precede echocardiographic indices of systolic and diastolic function among childhood cancer survivors treated with anthracyclines thus allowing evaluation of new therapies to prevent and manage heart failure in these patients.
Who can participate
Age range9 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
5.1 A. Subject Inclusion Criteria
* Childhood cancer survivors from the late effect clinic who had received ≥240 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 2 years.
* Age \> 9 years of age\*
* Parental/caregiver consent and subject assent to enrollment
\* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation B. Subject Inclusion Criteria
* Enrolled in part A of the study, which took place from October 2011 to July 2013.
* Parental/caregiver consent and subject assent to enrollment C. Subject Inclusion Criteria
* Childhood cancer survivors from the late effect clinic who had received \< 300 mg/m2 anthracyclines, been in complete remission and off chemotherapy for a minimum of 1 year
* Age ≥ 9 years of age\*
* Parental/caregiver consent and subject assent to enrollment
* \* Age \> 9 years of age was chosen to avoid the need for general anesthesia or sedation
5.2 A. Subject Exclusion Criteria
* Contraindications to CMRI.\*
* Pregnancy\*\*
\* Contraindications to CMRI (i.e., magnetically activated implants/devices; cardiac pacemaker or wires; after the patients are scheduled for CMRI, they will be sent our standard pre-MRI paperwork/questionnaire, to determine eligibility to have an MRI)
\*\*If a female patient of child bearing age is not sure if they are pregnant or not, as part of the standard CMRI with contrast procedures, a urine pregnancy test will be done. If the result is positive the s…
What they're measuring
1
To see if a CMRI is better at detecting occult asymptomatic cardiotoxicity