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NCT07912671

Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled study is to evaluate whether a wearable device-based, Life's Essential 8 (LE8)-guided management strategy can improve cardiovascular health in patients with chronic coronary syndrome (CCS). Approximately 400 participants will be randomly assigned in a 1:1 ratio to either a wearable device-based management group or a data-blinded control group. All participants will receive routine cardiology outpatient follow-up every 3 months for 12 months. Participants in the intervention group will be able to view selected smartwatch data and will receive health and medication reminders as well as individualized LE8 feedback. Participants in the control group will also wear the smartwatch for data collection, but the monitoring data, reminders, and LE8 feedback will not be made available to participants in the control group. The main question is whether the wearable device-based management strategy results in a greater improvement in the overall LE8 cardiovascular health score from baseline to 12 months compared with routine outpatient management.

Official title: Wearable Device-Based Long-Term Management of Coronary Artery Disease: The OPPO-WATCH Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-11-30

Completion Date

2028-12-31

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Chronic Coronary Syndrome

Interventions

DEVICE

Wearable Device-Based Monitoring and LE8 Feedback

The smartwatch displays monitoring information, including physical activity and sleep data, and continuously uploads collected data to the study platform through encrypted transmission. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system provides reminders related to insufficient physical activity, prolonged sedentary time, insufficient sleep, smoking cessation or reduction, diet, and medication use. After each in-person follow-up visit, the system integrates wearable data, questionnaire responses, and clinical measurements to generate an LE8 cardiovascular health score report for the participant, with individualized prompts for components that do not meet target levels. Follow-up physicians remain masked to wearable monitoring data and LE8 reports and provide clinical care and medication adjustments based on routine clinical information.

OTHER

Routine Outpatient Care With Data-Blinded Wearable Monitoring

The smartwatch displays only the time while collecting physical activity and sleep data. Monitoring data are not accessible to participants or follow-up physicians. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system does not provide health or medication reminders, scores, or feedback to participants. Collected data are encrypted and uploaded to a blinded backend for outcome assessment and quality control. LE8 scores are calculated automatically and exported for endpoint analysis after follow-up is completed. During routine in-person visits, physicians assess participants using clinical interviews, physical examinations, and necessary ancillary tests, and adjust medications and follow-up management without access to wearable monitoring data or LE8 scores.

Inclusion Criteria 1. Age ≥18 years. 2. Diagnosis of chronic coronary syndrome (CCS) according to the 2024 European Society of Cardiology (ESC) Guidelines for the Management of Chronic Coronary Syndromes. 3. Able and willing to provide written informed consent and comply with scheduled study follow-up. 4. Owns a smartphone and has sufficient ability to install, log in to, and routinely use the study application. 5. Baseline Life's Essential 8 (LE8) cardiovascular health score \<80 before randomization. Exclusion Criteria 1. Presence of an indication for coronary revascularization, as determined by the investigator according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes. 2. Acute heart failure, hemodynamic instability, or cardiogenic shock. 3. ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days before enrollment. 4. Clinically significant severe arrhythmias, including but not limited to: * Sustained or paroxysmal ventricular tachycardia or ventricular fibrillation; * Persistent atrial fibrillation or atrial flutter with inadequate ventricular rate control (resting heart rate \>100 beats/min); * High-grade or complete atrioventricular block; * Symptomatic bradycardia or arrhythmias requiring pacemaker support; * Other serious arrhythmias considered by the investigator to interfere with resting heart rate assessment or compromise participant safety. 5. Severe chronic heart failure with left ventricular ejection fraction (LVEF) ≤40%. 6. Severe hepatic or renal impairment, including clinically significant severe hepatic dysfunction, diagnosed Child-Pugh class B or C cirrhosis, or other severe hepatic impairment as judged by the investigator; or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m². 7. Malignancy or expected survival \<12 months. 8. Major bleeding within the previous 3 months, active bleeding, or any history of intracranial hemorrhage. 9. Anemia, defined as hemoglobin \<120 g/L in men or \<110 g/L in women. 10. Thyroid disease, unless treated with thyroid hormone replacement and clinically stable for ≥3 months. 11. Presence of an implanted pacemaker or implantable cardioverter-defibrillator. 12. Participation in another clinical study within the previous 12 months. 13. Presence of a high-risk condition related to exercise, a requirement for close medical supervision, or any condition considered by the investigator to make the participant unsuitable for home-based physical activity management or long-term follow-up. 14. Bariatric/metabolic surgery within the 12 months before screening, ongoing substantial postoperative weight loss, or planned bariatric/metabolic surgery during the study follow-up period. 15. Any other condition considered by the investigator to make the participant unsuitable for participation in the study.

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China