if Aortic StiffnessNCT01719094
RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors
An observational study of if Aortic Stiffness and Myocardial Wall Strain, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- if Aortic Stiffness, Myocardial Wall Strain
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Childhood cancer survivors, adolescent/young adults with no cancer history and newly diagnosed cancer patients
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Wake Forset University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
- Conditions
- if Aortic Stiffness, Myocardial Wall Strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Childhood Cancer Surviviors | Not described | |
| Adolescent/young adults with no cancer history | Not described | |
| Newly diagnosed cancer patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy
Measured: Day 1
Secondary outcomes (1)
To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients
n=25
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for if Aortic StiffnessStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon M Castellino, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719094
- Sponsor's protocol ID
- IRB00014375
- Other IDs
- CCCWFU 99312
- Status last verified
- Jul 2018
- First submitted
- 30 Oct 2012
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors
- ClinicalTrials.gov ID
- NCT01719094
- Acronym / sponsor ID
- IRB00014375
- Conditions
- if Aortic Stiffness, Myocardial Wall Strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Childhood Cancer Surviviors | – | – |
| Adolescent/young adults with no cancer history | – | – |
| Newly diagnosed cancer patients | – | – |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Childhood cancer survivors, adolescent/young adults with no cancer history and newly diagnosed cancer patients
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy
Time frame: Day 1
1 secondary outcome
To determine if aortic stiffness changes during treatment with anthracycline chemotherapy in childhood cancer patients
Time frame: approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon M Castellino, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of if Aortic Stiffness and Myocardial Wall Strain, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.