Completed

NCT Number: NCT01719094

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

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.

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Key information

Conditions

if Aortic Stiffness Myocardial Wall Strain

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University School of Medicine, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy

Time frame: Day 1

Secondary outcomes

To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients

Time frame: approximately 6 months

n=25

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Nov 1, 2012
Registry last updated: Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.