Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.

NCT07401550 | Recruiting

• 1 other identifier: BEA0247
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.

Conditions

Cardiovascular Diseases (CVD); Cardiovascular Disease Prevention; Cardiovascular Disease Risk Factor; Coronary Artery Disease (CAD)

Keywords

wearables; wearable devices; cardiovascular health; cardiovascular disease; wearable technology; fitbit; fitabase; remote monitoring; cardiovascular disease prevention; cardiovascular risk reduction; digital biomarker; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health

  The strength and direction of the associations between wearable-derived biometric data (e.g., heart rate, sleep, step count) and cardiovascular health, quantified using Life's Essential 8 score and each of its individual components. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health. Clinical cardiovascular assessments will be paired with wearable biometric data from a window of ±2 weeks surrounding the clinical visit date.

  Baseline, Month 3, and Month 6

• Longitudinal Association of Changes in Wearable Biometrics with Changes in Cardiovascular Health

  The strength and direction of the association between changes in wearable-derived biometrics and corresponding changes in cardiovascular health, quantified using Life's Essential 8 score and each of its components, assessed over time both within and between individuals. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health.

  Between assessments of cardiovascular health from baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.

Secondary Outcomes (4)

• Classification Performance for Life's Essential 8 Tier

  Baseline, Month 3, Month 6.

• Prediction Accuracy of Change in Life's Essential 8 Score

  From baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.

• Cross-Sectional Correlation of Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease

  Baseline, Month 3, Month 6.

• Longitudinal Correlation of Weekly and Monthly Changes in Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease

  Baseline through Month 6

Study Arms (1)

Patients with cardiovascular disease and healthy individuals

A single prospective cohort will be recruited, comprising predominantly individuals with atherosclerotic cardiovascular disease. Patients with mild, moderate and severe ASCVD will be recruited, including patients from cardiac rehabilitation physiotherapy classes and post-operative percutaneous coronary intervention (PCI) patients. A sub-group with good cardiovascular health - without diagnosed cardiovascular disease - will also be recruited as part of this cohort to facilitate analysis across the full spectrum of cardiovascular health and development of statistical models for cardiovascular health assessment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will primarily include patients with moderate or poor cardiovascular health who have been diagnosed with atherosclerosis and other cardiovascular disease. A smaller proportion of individuals with good cardiovascular health, without diagnosed cardiovascular disease, will also be recruited.

You may qualify if:

• Adults aged 18 years, or older
• Internet access
• Possession of a smartphone compatible with the Fitbit mobile app

You may not qualify if:

• Pregnancy
• Unstable medical condition
• Inability to provide informed consent
• Mental or cognitive impairment precluding adherence to study protocol
• Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)

Sponsors & Collaborators

• University College Dublin: lead
• Beacon Hospital, Ireland: collaborator

Study Sites (1)

Beacon Hospital

Dublin, Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Rory Lambe

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rory Lambe

CONTACT

+353 1 716 3442; rory.lambe@ucdconnect.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: February 10, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)