Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks

NCT ID: NCT06385431

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 8000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-28
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Metabolic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with cardiovascular and metabolic disease

observational study

Intervention Type: OTHER

obeservational study with none intervention

Interventions

observational study

obeservational study with none intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xiangqing Kong

director of the department of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangqing Kong, Phd

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Wei Sun, Phd

Role: CONTACT

shunwee@126.com

13815860536

Other Identifiers

Charm

Identifier Type: -

Identifier Source: org_study_id