Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Esophageal Neoplasms

Breast Neoplasms

Lung Neoplasms

Cardiotoxicity

Aggression

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Esophageal Cancer

Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

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.

Cardiac Aggressive Risk MitigAtion Plan

Katelyn Atkins, MD, PhD

The purpose of this study is to examine adherence to cardio-oncology consultation.

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.

Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.

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

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.

Proportion of participants who obtain EKG readings for at least 4 timepoints.

-The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings

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.

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.

* 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial	NCT05403736	Cancer	Cardiac Aggress...	18 Years -	Cedars-Sinai Medical Center
Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial	NCT05403736	Cancer	Cardiac Aggress...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for cardiac aggressive risk mitigation plan