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RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01719094
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Cardiovascular events are the leading non-cancer cause of mortality after childhood cancer, occurring at a significantly younger age than in the general population. The increased incidence of cardiovascular events adversely impacts the functional capacity, morbidity, and mortality of otherwise relatively healthy 20 to 40 year old individuals. Moreover, understanding of the mechanisms by which cancer treatment could influence the occurrence of latent cardiovascular events is unavailable. Our group and others have established independent, noninvasive magnetic resonance imaging (MRI) measures of cardiovascular risk in middle aged and elderly individuals. Cardiovascular risk include, acute coronary syndromes, cardiac death, and congestive heart failure. The goal of this application is to show that childhood cancer survivors at risk for impaired cardiovascular and cerebrovascular health have increased aortic stiffness, when compared to healthy adolescent and young adult age mate. Studies are designed to determine if MRI measures of cardiovascular function differ between adolescent/adult childhood cancer survivors (n=60), age matched controls (n=30), and adolescents/young adults with planned treatment with chemo- and radiation therapy (n=25). The investigators propose that MRI markers responsible for cardiovascular events represent new clinical indicators that could be targeted to treat asymptomatic cardiovascular diseases.

Condition or disease
if Aortic Stiffness Myocardial Wall Strain

Study Design

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors
Study Start Date : August 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015
Groups and Cohorts

Group/Cohort
Childhood Cancer Surviviors
Adolescent/young adults with no cancer history
Newly diagnosed cancer patients


Outcome Measures

Primary Outcome Measures :
  1. To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients [ Time Frame: approximately 6 months ]
    n=25


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Childhood cancer survivors, adolescent/young adults with no cancer history and newly diagnosed cancer patients
Criteria

Inclusion Criteria:

Childhood Cancer Survivors

  • Diagnosis of cancer at age 21 or younger
  • Current age 16-40 years
  • 1year and ≤ 15 years from end of cancer treatment
  • Received anthracycline chemotherapy
  • Asymptomatic (Appendix VII: absence of palpitations, dyspnea, edema or anginal symptoms)
  • No pre-existing diagnosis with regard to cardiovascular or cerebrovascular disease status.

Adolescent/young adults with no cancer history

  • No prior diagnosis of cancer, diabetes, or lung disease
  • Current age 16-40 years
  • No history of radiation to chest or neck
  • No prior history of chemotherapy
  • Asymptomatic (Appendix VII : absence of palpitations, dyspnea, edema or anginal symptoms) and without a pre-existing diagnosis with regard to cardiovascular or cerebrovascular disease status.

Newly diagnosed cancer patients

  • Diagnosis of cancer at age 25 or younger
  • Current age 7-25 years
  • Planned receipt of anthracycline chemotherapy
  • Planned treatment course ≤ 15 months
  • No pre-existing cardiovascular disease

Exclusion Criteria:

All groups

  • Subjects with implanted electronic devices, including but not limited to: pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
  • Subjects with ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
  • Claustrophobia
  • Subjects who received total body irradiation or cranial irradiation
  • History of acute myocardial infarction
  • Significant ventricular arrhythmias (>20 PVC's/minute due to gating difficulty)
  • Medical history of moderate or severe aortic stenosis, or other significant valvular disease
  • Women who are pregnant
  • Those with pre-existing history (by self report in Group B and review of medical records in addition to self-report for Groups A & C) of abnormal cardiovascular function including: congenital heart disease, hypertension, diabetes, hypercholesterolemia on treatment, a body mass index >35, history of asymptomatic cardiac dysfunction (defined as an ejection fraction < 40 and/or shortening fraction < 28) or symptomatic cardiac dysfunction (congestive heart failure), stroke, renal dysfunction by history/medical records (serum creatinine >1.4), anemia, obstructive or restrictive airways disease
  • Asymptomatic cardiac dysfunction (defined as an ejection fraction < 40 and/or shortening fraction < 28 on last ECHO or MUGA)
  • Participants unwilling to complete the protocol (1 visit for Group A, B; 3 scan studies for Group C)
  • Participants unable to provide informed consent via a guardian or self
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719094


Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, North Carolina
Wake Forset University Health Sciences
Winston-Salem, NC, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Sharon M Castellino, MD Wake Forest University Health Sciences
More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01719094     History of Changes
Other Study ID Numbers: CCCWFU 99312
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No