None listed
Conditions
Brief summary
Brief description of the study purpose: This pilot study aims to identify whether a two-step risk screening pathway can accurately detect early, often symptom-free heart dysfunction that may occur after cancer treatment. Who is it for? You may be eligible for this study if you are male or female age 40 years or older, who have completed cancer treatment that may affect the heart (such as chemotherapy, radiotherapy to the chest, or targeted therapies) and are eligible for Medicare. Study details: Participants will attend a single study visit. No treatment is given as part of this study. At the visit, participants will first complete a clinical risk questionnaire (CHERISH) that estimates their risk of heart failure. They will then undergo a standard 12-lead electrocardiogram (ECG), which is analysed using an artificial intelligence program to estimate the chance of early heart dysfunction. All participants will also undergo a standard heart ultrasound, which measures heart function and is used as the reference test. There is no therapeutic intervention, and the screening results are not used to guide clinical care during the study. It is hoped that the findings will help design a larger multicentre study and could support scalable, low-cost heart screening for cancer survivors and other high-risk groups.
Interventions
All participants undergo a single study visit comprising a two-step sequential screening pathway followed by reference-standard echocardiography. No therapeutic intervention is administered; the screening outputs are investigational and are not used to guide clinical care during the study.
Step 1 — CHERISH risk score: A previously developed clinical risk score for heart failure in cancer survivors is calculated for every participant from self-reported categorical clinical items and basic demogr
All participants undergo a single study visit comprising a two-step sequential screening pathway followed by reference-standard echocardiography. No therapeutic intervention is administered; the screening outputs are investigational and are not used to guide clinical care during the study. Step 1 — CHERISH risk score: A previously developed clinical risk score for heart failure in cancer survivors is calculated for every participant from self-reported categorical clinical items and basic demographics (no medical-record access required). Participants with a score greater than or equal to 3% are classified as high risk (screen positive at this step). The publicly available calculator is at https://baker-biostats.shinyapps.io/CHERISH/. The CHERISH risk score will be documented in the research database (REDCap). Step 2 — AI-enabled electrocardiography (AI-ECG): All participants undergo a standard, resting 12-lead energy waveform ECG (ewECG) using the MyoVista device (version 2.0; HeartSciences, Southlake, Texas, USA) performed by research assistant. An integrated, non-adaptive (fixed-parameter) machine-learning algorithm automatically generates a probability score (0–1) for subclinical cardiac dysfunction, displayed alongside the ECG trace. A probability of greater than or equal to 0.61 is classified as screen positive. Acquisition requires no procedure beyond standard 12-lead ECG and will take no more than 15 minutes. The AI-ECG risk probability will be documented in the research database (REDCap). Under the sequential framework, a participant is screen positive if either (1) CHERISH-defined high risk, or (2) AI-ECG-positive among those initially low risk. Duration of observation: Cross-sectional: a single visit per participant with no follow-up. All assessments occur within that one visit.
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged greater than or equal to 40 years 2. Completed primary cancer therapy that is potentially cardiotoxic (chemotherapy, chest radiotherapy, or targeted therapy [e.g. trastuzumab]) 3. Eligible for Medicare 4. Able to provide written informed consent
Exclusion criteria
1. Prior diagnosis of symptomatic heart failure 2. Moderate or severe valvular heart disease 3. Active cancer requiring ongoing treatment 4. Life expectancy less than 12 months due to concomitant disease 5. Inability to undergo ECG or echocardiographic assessment 6. Participation in another clinical research trial
Outcome results
None listed