Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Connecticut Children's Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Olga Salazar, Connecticut Children's Medical Center Identifier:
First received: August 21, 2012
Last updated: NA
Last verified: May 2011
History: No changes posted
The main hypothesis being tested is that imaging and serologic biomarkers of apoptosis and progressive 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.

Condition Intervention
Cardiovascular Disease
Other: Cardiac MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy: A Cardiac Magnetic Resonance and Biomarker Imaging and Serological Biomarker Study

Further study details as provided by Connecticut Children's Medical Center:

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cardiac MRI
    Cardiac MRI

Ages Eligible for Study:   9 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Survivors of childhood cancer who were treated with anthracyclines and are greater than 2 years from their last cycle of chemotherapy

Inclusion Criteria:

  • Childhood cancer survivors from the late effect clinic who had been in continuous, complete remission and off chemotherapy for a minimum of 2 years.
  • Age > 9 years of age

Exclusion Criteria:

  • Contraindications to CMRI
  • Relapse of their cancer
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01671696

United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Principal Investigator: Olga Salazar, MS Connecticut Childrens Med Ctr
  More Information

Responsible Party: Olga Salazar, Assistant Clinical Professor, Pediatric Cardiology, Connecticut Children's Medical Center Identifier: NCT01671696     History of Changes
Other Study ID Numbers: CardiacMRI 
Study First Received: August 21, 2012
Last Updated: August 21, 2012

Additional relevant MeSH terms:
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries processed this record on January 19, 2017