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Research and Development of Monitoring Device for Full-Cycle Management of Cardiovascular Diseases and Construction of Intelligent Traditional Chinese Medicine Diagnosis and Treatment System

Research and Development of Monitoring Device for Full-Cycle Management of Cardiovascular Diseases and Construction of Intelligent Traditional Chinese Medicine Diagnosis and Treatment System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125156
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Hypertension, Chronic Heart Failure, Arrhythmia, T2DM, hyperlipidemia, etc.

Interventions

Heart group:None
Health group:None

Sponsors

The First Affiliated Hospital of Hunan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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

MeasureTime frame
AUC for cardiovascular event prediction;

Secondary

MeasureTime 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

Public ContactLiang Hao

The First Affiliated Hospital of Hunan University of Chinese Medicine

lianghao118@163.com+86 731 88459551

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026