Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks (Charm)

Nanjing Medical University

Status: Not yet enrolling

Conditions: Metabolic Disease

Treatments: Other: observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06385431

Charm

Details and patient eligibility

About

Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.

In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1.18 years old ≤ age ≤70 years old; 2. Have ≥1 cardiovascular and metabolic disease:

1. hypertension (systolic blood pressure ≥140mmHg in the resting room and diastolic blood pressure ≥90mmHg in the rest room;Previously diagnosed and taking blood pressure medication);
2. Dyslipidemia: [LDL-C≥4.1mmol/L and/or HDL-C<1.0mmol/L and/or TC≥6.2mmol/L and/or TG≥2.3mmol/L];
3. fatty liver;
4. Obesity (BMI≥28kg/m2 or waist circumference: male ≥90cm, female ≥85cm);
5. Abnormal glucose metabolism:

Impaired fasting blood glucose: fasting blood glucose ≥6.1, <7.0mmol/L, 2h post-glucose load blood glucose<7.8mmol/L And/or impaired glucose tolerance: fasting blood glucose<6.1mmol/L, 2h post-glucose load blood glucose ≥7.8,<11.1mmol/L and/or HbA1c≥5.7, <6.5%; 3. Subjects voluntarily participate in the study

Exclusion criteria

1. Diagnosed type 1 and/or type 2 diabetes;
2. Confirmed history of secondary hypertension (renal parenchymatous hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, obstructive sleep apnea hypopnea syndrome, etc.);
3. A history of malignant tumors (other than non-metastatic skin basal cell carcinoma or squamous cell carcinoma or cervical cancer in situ that has been appropriately treated or resected);
4. Severe structural heart disease (including valvular heart disease, cardiomyopathy, congenital heart disease);
5. Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack in the last 6 months;
6. History of cardiovascular and cerebrovascular surgery/interventional treatment (stent, balloon, thrombectomy, etc.);
7. Pregnant women or those who are breastfeeding;
8. Patients with clear immune system abnormalities (systemic lupus erythematosus, etc.);
9. Impaired liver and kidney function (ALT, AST more than 3 times the upper limit of normal, eGFR(CKD-EPI)≤60 mL/min/1.73m2);
10. Patients who cannot follow through on screening.

Trial design

8,000 participants in 1 patient group

Patients with cardiovascular and metabolic disease

Treatment:

Other: observational study