CancerCARMANCT05403736
Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
A study testing Cardiac Aggressive Risk MitigAtion Plan in people with Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine adherence to cardio-oncology consultation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Cardiac Aggressive Risk MitigAtion Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2022to 16 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field.
- Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Planning to receive standard of care radiotherapy treatments.
- Access to a smart device that has the capability to sync to the devices.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Ability to read, write and understand English.
Who cannot join
- Known allergy to surgical steel or elastomer/rubber.
- Heart attack within 6 months prior to study enrollment.
- Severe and/or active scleroderma or systemic lupus erythematosus.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Clinical Trials Office
Los Angeles, California, 90048
About this study
Official title: IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
The purpose of this study is to examine adherence to cardio-oncology consultation.
Read the detailed description
The purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. In addition, the study will evaluate use of wearable devices such as a FitBit, and remote EKG (Omron EVOLV) and blood pressure monitoring (AliveCor KardiaMobile) devices to monitor participant's health. Blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism.
Study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.
- Conditions
- Cancer
- Being tested
- Cardiac Aggressive Risk MitigAtion Plan
- Keywords
- radiation therapy, cardio-oncology, cardiology, cardiac toxicity, lung cancer, esophageal cancer, breast cancer, thoracic radiotherapy
- Medical subject headings
- Neoplasms, Cardiotoxicity, Lung Neoplasms, Esophageal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Aggressive Risk MitigAtion PlanOther
Also called FitBit, Omron EVOLV Automatic Blood Pressure Monitor, AliveCor KardiaMobile Personal EKG Monitor, cardio-oncology consultation
Cardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices.
| Study group | Role | What they receive |
|---|---|---|
| CARMA | Experimental | Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring Receives: Other: Cardiac Aggressive Risk MitigAtion Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the cardio-oncology consultation visit
Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.
Measured: From baseline to 3 months
Secondary outcomes (6)
Number of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit
Proportion of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit
Measured: From baseline to 3 months
Number of participants who obtain blood pressure readings for at least 4 timepoints
Proportion of participants who obtain blood pressure readings for at least 4 timepoints.
-The Omron blood pressure monitor will be used to obtain blood pressure readings.
Measured: From baseline to 3 months
Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints
Proportion of participants who obtain EKG readings for at least 4 timepoints.
-The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings
Measured: From baseline to 3 months
Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist
Number of participants provided recommendation to either initiate, or modify the dose of, a cardiovascular risk-reducing medication (anti-lipid, anti-platelet, anti-coagulation, anti-hypertensive). Expressed as the number of participants as a fraction of the total number of participants.
Measured: From baseline to 3 months
Rate of compliance with cardiovascular therapeutic medication intervention
Compliance will be assessed by self-reporting of medication usage at the 3-month follow-up and defined as yes or no for all recommended cardiovascular therapeutic medication interventions. Expressed as the number of participants as a fraction of the total number of participants.
Measured: From baseline to 3 months
Evaluate participant intervention perspectives at the end of the study.
- Analyze participate attitudes and perspectives on implementation and impact of the cardiovascular intervention plan. Participants will be asked to complete a survey at the 3-month visit.
- Each question is either answered on a scale of 1-4 or strongly agree-strongly disagree, where higher scores indicate the highest level of burden or disagreement, respectively.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start7 Oct 2022
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katelyn Atkins, Cedars-Sinai Medical Center
- Investigators
- Katelyn Atkins, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403736
- Sponsor's protocol ID
- IIT2021-07-Atkins-CARMA
- Acronym
- CARMA
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data (including data dictionaries) supporting the manuscript findings will be shared beginning three months after publication and without end date with qualified investigators whose proposed use of the data has been approved by an institutional review board and following execution of a data use agreement per Cedars-Sinai Medical Center institutional policy. The study protocol will additionally be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
- ClinicalTrials.gov ID
- NCT05403736
- Acronym / sponsor ID
- CARMA / IIT2021-07-Atkins-CARMA
- Conditions
- Cancer
- Keywords
- radiation therapy, cardio-oncology, cardiology, cardiac toxicity, lung cancer, esophageal cancer, breast cancer, thoracic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- 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.
The purpose of this study is to examine adherence to cardio-oncology consultation.
Detailed description
The purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. In addition, the study will evaluate use of wearable devices such as a FitBit, and remote EKG (Omron EVOLV) and blood pressure monitoring (AliveCor KardiaMobile) devices to monitor participant's health. Blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism.
Study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| CARMA | Experimental | Other: Cardiac Aggressive Risk MitigAtion PlanCardiac Aggressive Risk MitigAtion plan with biosensor monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field.
- Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Planning to receive standard of care radiotherapy treatments.
- Access to a smart device that has the capability to sync to the devices.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (3 listed)
- Known allergy to surgical steel or elastomer/rubber.
- Heart attack within 6 months prior to study enrollment.
- Severe and/or active scleroderma or systemic lupus erythematosus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Aggressive Risk MitigAtion PlanAlso: FitBit, Omron EVOLV Automatic Blood Pressure Monitor, AliveCor KardiaMobile Personal EKG Monitor, cardio-oncology consultationCardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices. | Other | CARMA |
Primary outcome
Number of participants who complete the cardio-oncology consultation visit
Time frame: From baseline to 3 months
Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.
6 secondary outcomes
Number of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit
Time frame: From baseline to 3 months
Number of participants who obtain blood pressure readings for at least 4 timepoints
Time frame: From baseline to 3 months
Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints
Time frame: From baseline to 3 months
Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist
Time frame: From baseline to 3 months
Rate of compliance with cardiovascular therapeutic medication intervention
Time frame: From baseline to 3 months
Evaluate participant intervention perspectives at the end of the study.
Time frame: At 3 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 6 Feb 2025.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data (including data dictionaries) supporting the manuscript findings will be shared beginning three months after publication and without end date with qualified investigators whose proposed use of the data has been approved by an institutional review board and following execution of a data use agreement per Cedars-Sinai Medical Center institutional policy. The study protocol will additionally be shared.
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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.
Katelyn Atkins, MD, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Aggressive Risk MitigAtion Plan in people with Cancer, run by Cedars-Sinai Medical Center at 1 site 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 6 inclusion and 3 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of participants who complete the cardio-oncology consultation visit (time frame: From baseline to 3 months). 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 6 Feb 2025.