Clinical trial NCT06385431: Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks
Official title: Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants were patients aged 18-70 years with cardiovascular and metabolic disease

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.


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.

Primary outcomes:
measure: incidence rate of cardiovascular and metabolic diseases
timeFrame: 2024.04-2026.04
measure: treatment rate of cardiovascular and metabolic diseases
timeFrame: 2024.04-2026.04
measure: control rate of cardiovascular and metabolic diseases.
timeFrame: 2024.04-2026.04
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiangqing Kong, Phd
role: STUDY_DIRECTOR
References: