Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks

NCT06385431 | Not Yet Recruiting DMC

• 1 other identifier: Charm
• Study Type: observational
• Target: 8,000
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• incidence rate of cardiovascular and metabolic diseases

  Describe the incidence rate of cardiovascular and metabolic diseases(%).

  2024.04-2026.04

• 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

• 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

Study Arms (1)

Patients with cardiovascular and metabolic disease

Other: observational study

Interventions

observational study OTHER

obeservational study with none intervention

Patients with cardiovascular and metabolic disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants were patients aged 18-70 years with cardiovascular and metabolic disease

You may qualify if:

• years old ≤ age ≤70 years old; 2. Have ≥1 cardiovascular and metabolic disease:
• 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);
• Dyslipidemia: \[LDL-C≥4.1mmol/L and/or HDL-C\<1.0mmol/L and/or TC≥6.2mmol/L and/or TG≥2.3mmol/L\];
• fatty liver;
• Obesity (BMI≥28kg/m2 or waist circumference: male ≥90cm, female ≥85cm);
• 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

You may not qualify if:

• Diagnosed type 1 and/or type 2 diabetes;
• 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.);
• 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);
• Severe structural heart disease (including valvular heart disease, cardiomyopathy, congenital heart disease);
• Myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack in the last 6 months;
• History of cardiovascular and cerebrovascular surgery/interventional treatment (stent, balloon, thrombectomy, etc.);
• Pregnant women or those who are breastfeeding;
• Patients with clear immune system abnormalities (systemic lupus erythematosus, etc.);
• Impaired liver and kidney function (ALT, AST more than 3 times the upper limit of normal, eGFR(CKD-EPI)≤60 mL/min/1.73m2);
• Patients who cannot follow through on screening.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Xiangqing Kong, Phd

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Wei Sun, Phd

CONTACT

13815860536; shunwee@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of the department of cardiology

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 26, 2024
• Study Start: April 28, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share