NCT07912671Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Wearable Device-Based Long-Term Management of Coronary Artery Disease: The OPPO-WATCH Study
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 10 Oct 2026
- Start date
- 30 Nov 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Coronary artery disease
- NCT number
- NCT07912671
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 30 Nov 2026 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days before enrollment.
- Major bleeding within the previous 3 months, active bleeding, or any history of intracranial hemorrhage.
- Thyroid disease, unless treated with thyroid hormone replacement and clinically stable for ≥3 months.
- Participation in another clinical study within the previous 12 months.
- 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.
Other illness
- 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.
- Acute heart failure, hemodynamic instability, or cardiogenic shock.
- 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.
- Malignancy or expected survival \<12 months.
- 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.
- Any other condition considered by the investigator to make the participant unsuitable for participation in the study.
Lab values
- Severe chronic heart failure with left ventricular ejection fraction (LVEF) ≤40%.
- 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.
- Anemia, defined as hemoglobin \<120 g/L in men or \<110 g/L in women.
Other
- Presence of an implanted pacemaker or implantable cardioverter-defibrillator.
Who the study is looking for
- Age ≥18 years.
- Diagnosis of chronic coronary syndrome (CCS) according to the 2024 European Society of Cardiology (ESC) Guidelines for the Management of Chronic Coronary Syndromes.
- Able and willing to provide written informed consent and comply with scheduled study follow-up.
- Owns a smartphone and has sufficient ability to install, log in to, and routinely use the study application.
- Baseline Life's Essential 8 (LE8) cardiovascular health score \<80 before randomization.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.