Coronary Heart Disease, Hypertension, Chronic Heart Failure, Arrhythmia, T2DM, hyperlipidemia, etc.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Cardiovascular Disease Patient Group (Heart Group) 1. Aged 18–75 years, with no restriction on gender; 2. Voluntarily signed the informed consent form, fully understood the research objectives, procedures, risks, and benefits, and possessed the capacity to cooperate in completing the study; 3. Met the diagnostic criteria for cardiovascular diseases in Western medicine and/or the syndrome differentiation standards in Traditional Chinese Medicine (TCM), and were at any stage of the full-cycle management of cardiovascular disease (pre-disease, impending disease, established disease, or post-recovery); 4. Wrist circumference fell within the adaptable range of the novel smartwatch, with no contraindications for wearing the device; 5. Owned a smartphone and were proficient in installing and operating the study APP, ensuring normal data upload during the study period; 6. Willing to provide TCM four-diagnosis information, Western medicine clinical indicators, public health data, etc., as required by the study, and to cooperate with the 12-month follow-up plan (including hospital visits for physical examinations and questionnaire completion at the 6th and 12th months). Healthy Volunteer Group (Health Group) 1. Aged 18–75 years, with no restriction on gender; 2. Voluntarily signed the informed consent form, fully understood the research objectives, procedures, risks, and benefits, and possessed the capacity to cooperate in completing the study; 3. Confirmed by baseline physical examination and relevant tests to have no major cardiovascular diseases or severe underlying conditions, with basically normal TCM constitution identification; 4. Wrist circumference fell within the adaptable range of the novel smartwatch, with no contraindications for wearing the device; 5. Owned a smartphone and were proficient in installing and operating the study APP, ensuring normal data upload during the study period; 6. Willing to provide TCM four-diagnosis information, Western medicine clinical indicators, public health data, etc., as required by the study, and to cooperate with the 12-month follow-up plan (including hospital visits for physical examinations, relevant tests, and questionnaire completion at the 6th and 12th months).
Exclusion criteria
Exclusion criteria: Cardiovascular Disease Patient Group (Heart Group) 1. Patients with severe mental disorders or cognitive impairment (e.g., MMSE score 3 times the upper limit of normal, Cr > 2 times the upper limit of normal), advanced-stage malignant tumors, or other severe diseases with a life expectancy of < 1 year. 6. Other circumstances deemed by the investigator as unsuitable for participation in this study. Healthy Volunteer Group (Health Group) 1. Individuals with severe skin lesions, deformities, or burns on the wrist, or known allergies to silicone or metal, making them unable to wear the smartwatch. 2. Individuals currently participating in other interventional clinical trials that may affect the results of this study. 3. Other circumstances deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC for cardiovascular event prediction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cross-modal alignment accuracy;Consistency between quantified TCM health status and clinical expert assessment;Consistency of key risk factor identification with clinical guidelines;Accuracy of large model in TCM pattern discrimination reasoning tasks;Rationality of prescription generation; | — |
Countries
China
Contacts
The First Affiliated Hospital of Hunan University of Chinese Medicine