High risk cardiovascular disease population
Conditions
Interventions
Standard Care Group:Comprehensive intervention
CTA-Guided Group:Comprehensive intervention based on CTA guidance
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Village Selection Criteria: 1. Administrative village; 2. The village has no plans to merge with other villages within the next 3 years; 3. The village is at least 2 kilometers away from other villages participating in the project; 4. The village has a sufficient number of research participants; 5. The village is able to cooperate with the implementation of the study. Research Participant Selection Criteria: 1. Aged between 40 and 75 years; 2. Residing stably in the province where the study is conducted and has no plans to leave the province in the next 3 years; 3. Not participating in other clinical trials; 4. Meets any of the following conditions: (1) LDL-C >= 4.9 mmol/L or TC >= 7.2 mmol/L; (2) Diabetic patients; (3) CKD stages 3~4 (15 mL/min/1.73m^2 = 1.8 mmol/L or TC >= 3.1 mmol/L; (5) Hypertensive patients with 2 risk factors, combined with LDL-C >= 2.6 mmol/L or TC >= 4.1 mmol/L. Risk factors include smoking, low HDL-C, and age >= 45 for men or >= 55 for women, with risk factor levels being those measured before the intervention; 5. Signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Unwillingness or inability to undergo coronary CTA examination (e.g., previous history of severe contrast allergic reactions, claustrophobia, or inability to cooperate with scanning and breath-holding for physical reasons in study participants); 2.Typical angina symptoms, known coronary artery disease, or other major atherosclerotic cardiovascular disease; 3.Known cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction, etc. ); 4.Previous invasive or non-invasive coronary angiography within the last 5 years; 5.Known familial hypercholesterolemia or other hereditary lipid dysfunction disorders requiring lipid-lowering therapy; 6.Presence of active bleeding or diseases with a very high risk of bleeding (e.g., active peptic ulcer disease, gastrointestinal pathologies with increased risk of bleeding, hematologic disorders with increased risk of bleeding, etc. ); 7.End-stage diseases such as cirrhosis decompensation, with life expectancy 2 years; 11.Pregnant or breastfeeding, planning to become pregnant within the next 3 years; 12.eGFR <30 mL/min/1.73m^2; 13.Platelet count <100×10^9/L; 14.Poor compliance, unable to cooperate with study investigators; 15.Investigators consider unsuitable for participants selected for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE at 18 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause death at 18 months;Myocardial infarction at 18 months;Stroke at 18 months;Hospitalization for chest pain at 18 months;Coronary revascularization at 18 months;Invasive coronary angiography at 18 months;The proportion of antiplatelet drugs and lipid-lowering drugs used from baseline to 18 months;Changes in lipid levels from baseline to 18 months;Quality of life changes from baseline to 18 months;MACE at 36 months;CTA-related safety endpoints;Lipid-lowering therapy-related safety endpoints;Antiplatelet therapy-related safety endpoints; | — |
Countries
China
Contacts
Public ContactBo Yu
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed