Clinical trial · Interventional
Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
NCT05403736CI-TRIAL-00085566CARMAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to examine adherence to cardio-oncology consultation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac Aggressive Risk MitigAtion Plan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CARMA
- description
- Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring
- interventionNames
- Other: Cardiac Aggressive Risk MitigAtion Plan
Primary outcomes (1)
- measure
- Number of participants who complete the cardio-oncology consultation visit
- timeFrame
- From baseline to 3 months
- description
- Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.
Secondary outcomes (6)
- measure
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.