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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• Presence of an implanted pacemaker or implantable cardioverter-defibrillator.

• 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.