Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Cardiac Aggressive Risk MitigAtion Plan

• Registration Number: NCT05403736
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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 Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Study Start: 2022-10-07
• Primary Completion: 2023-06-16
• Study Completion: 2023-06-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CARMA	Cardiac Aggressive Risk MitigAtion Plan	Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Primary Outcome Measures

Name	Time	Method
Number of participants who complete the cardio-oncology consultation visit	From baseline to 3 months	Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.

Secondary Outcome Measures

Name	Time	Method
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	From baseline to 3 months	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
Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints	From baseline to 3 months	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 who obtain blood pressure readings for at least 4 timepoints	From baseline to 3 months	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.
Rate of compliance with cardiovascular therapeutic medication intervention	From baseline to 3 months	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.
Evaluate participant intervention perspectives at the end of the study.	At 3 months	* 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.
Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist	From baseline to 3 months	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.

Trial Locations

Locations (1)

Cancer Clinical Trials Office; 🇺🇸 Los Angeles, California, United States