Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks

Metabolic Disease Clinical Trial

— Charm  

Official title:

Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385431
• Other study ID #: Charm
• Status: Not yet recruiting
• Start date: April 28, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Wei Sun, Phd
• Phone: 13815860536
• Email: shunwee[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8000
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• observational study
obeservational study with none intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of cardiovascular and metabolic diseases	Describe the incidence rate of cardiovascular and metabolic diseases(%).	2024.04-2026.04
Primary	treatment rate of cardiovascular and metabolic diseases	Describe the treatment rate of cardiovascular and metabolic diseases(%):the number of subjects with treatment/number of all subjects	2024.04-2026.04
Primary	control rate of cardiovascular and metabolic diseases.	Describe the control rate of cardiovascular and metabolic diseases. (%) number of subjects with effective treatment/ number of subjects with treatment	2024.04-2026.04