An Epidemiological and Long-Term Endpoint Registry Study on Disease-Syndrome Correlation Patterns in Comorbid Population With Diabetes and Ischemic Cardio-Cerebrovascular Disease

Guangzhou University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Cardiovascular Complications; Type 2 Diabetes Mellitus (T2DM)

Study type: Observational

Funder types: Other

Identifiers

NCT07104422

2023ZD0505601

An Epidemiological and Long-Te (Other Grant/Funding Number)

Details and patient eligibility

About

Explore the characteristics of TCM syndrome elements and distribution patterns of syndrome types in comorbid populations; Screen for "high-risk syndrome patterns" and frequently co-occurring complex syndromes; Identify characteristic syndrome patterns at key stages: acute phase, recovery phase, and upon occurrence of endpoint events; Investigate the temporal evolution of TCM syndrome patterns and the disease-syndrome correlation patterns in comorbid patients.

Full description

A registry study of 12,000 real-world patients with comorbidities is conducted to collect and investigate the epidemiological characteristics of populations with "Tang-Nao" (diabetes with cerebrovascular disease), "Tang-Xin" (diabetes with cardiovascular disease), and triple comorbidities. Through syndrome epidemiology surveys, multi-timepoint cross-sectional investigations on the TCM syndrome of "Toxin Damaging Collaterals" are performed to explore the characteristics of TCM syndrome elements and distribution patterns of syndrome types in comorbid populations, screen "high-risk syndromes" and frequently co-occurring complex syndromes, identify characteristic syndromes at acute phase, recovery phase, and upon occurrence of endpoint events, and investigate the evolution of TCM syndromes and disease-syndrome correlation patterns in comorbid patients.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥ 18 years Diagnosed with comorbidities relevant to "toxin-damaged collaterals" theory (e.g., type 2 diabetes mellitus with cardiovascular/cerebrovascular disease).

Voluntary participation with signed informed consent.

Exclusion criteria

• Acute infectious diseases, malignant tumors, or autoimmune disorders. Mental illness or cognitive impairment affecting symptom assessment.

Trial design

12,000 participants in 1 patient group

T2DM-CVD, T2DM-CeVD，T2DM-CVD&CeVD

Description:

T2DM-CVD: Type 2 diabetes with ischemic cardiovascular disease (coronary artery disease/heart failure), excluding cerebrovascular involvement. 2. T2DM-CeVD: Type 2 diabetes with ischemic cerebrovascular disease (ischemic stroke/TIA), excluding cardiovascular involvement. 3. T2DM-CVD\&CeVD: Type 2 diabetes comorbid with both ischemic cardiovascular and cerebrovascular diseases.