WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07058064
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electrocardiogram — PROCEDURE
    All participants receive a standard 12-lead ECG when they present for follow-up 1 year after completion of anthracycline-based therapy. All participants will also record a 6-lead Kardia (AliveCor, Mountain View, CA, USA) and 1-lead Apple Watch (Apple, Cupertino, CA, USA) ECG with Mayo-owned or participant-owned devices. Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.
  • Echocardiogram — PROCEDURE
    All participants will have an echocardiogram as part of standard of care when they present for their follow-up 1 year after completion of anthracycline-based therapy.
  • LVEF echocardiogram — PROCEDURE
    Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
  • Apple Watch — OTHER
    Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs. Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.
  • Biospecimen collection — PROCEDURE
    Undergo blood draw
  • Questionnaires — OTHER
    Participants fill out 2 questionnaires: 1) the Kansas City Cardiomyopathy-12 (KCCQ-12) Questionnaire, and 2) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ore 30 (EORTC QLQ-C30) to evaluate health related quality of life and heart failure symptoms.
  • Cardio-pulmonary exercise test — OTHER
    Undergo CPET to assess the response of heart and lungs to exercise.
  • 6 minute walk test — OTHER
    Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
  • Grip strength test — OTHER
    A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm

Study Details

The purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Mobile device-based artificial intelligence (AI)-electrocardiogram (ECG) can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.

Key Dates

Start date
Jul 18, 2025
Status verified
Oct 2025
Primary completion
Jun 29, 2029
Completion
Jun 29, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Active Comparator: Cross-sectional Arm
    Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
  • Experimental: Longitudinal Arm
    Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.

Primary Outcome Measure

Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG [ Time Frame: Baseline to 1 year follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Tera Peck
[email protected]
507-538-7425
Clinical Trials Referral Office
[email protected]
855-776-0015
Joerg Herrmann, MD (PRINCIPAL_INVESTIGATOR)

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