Real-world cardiometabolic protection outcomes

REal-world Data of CARdiometabolic ProtEcTion

This project will test whether common cardiometabolic risk factors predict death and major heart-related events in adults with hypertension, diabetes, obesity, dyslipidemia, or high uric acid.

Quick facts

• Study type: Observational
• Enrollment: 40000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07038083 on ClinicalTrials.gov

What this trial studies

This single-center, historical prospective cohort uses clinical records from the First Affiliated Hospital of Sun Yat-sen University to follow adults diagnosed with cardiometabolic conditions. Eligible patients are those aged 18 or older with diagnoses such as hypertension, diabetes, overweight/obesity, dyslipidemia, or hyperuricemia based on standard clinical criteria. The primary outcomes are all-cause death and cardiovascular death, and the secondary outcome is major adverse cardiovascular events (MACE). The study will measure associations between established or suspected cardiometabolic risk factors and these outcomes in a real-world representative cohort.

Who should consider this trial

Good fit: Adults aged 18 or older treated at the First Affiliated Hospital of Sun Yat-sen University with a clinical diagnosis of hypertension, diabetes, overweight/obesity, dyslipidemia, or hyperuricemia are ideal candidates.

Not a fit: People without cardiometabolic conditions, those under 18, or patients treated exclusively outside the enrolling hospital with no accessible records are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify which cardiometabolic risk factors most strongly predict death or major heart events and better target prevention and management.

How similar studies have performed: Large cohort studies have previously linked cardiometabolic risk factors to mortality and cardiovascular events, so this work seeks to confirm and refine those associations in a real-world Chinese hospital cohort.

Eligibility criteria

Inclusion Criteria:

* Patients over 18 years old;
* Patients with clinical diagnosis of metabolic cardiovascular disease, including hypertension, diabetes, obesity, dyslipidemia, hyperuricemia.

  1. Hypertension and normal high blood pressure: Three standardized blood pressure measurements in the clinic on different days, and all the blood pressure values of the three measurements were systolic blood pressure ≥ 120 mmHg and/or diastolic blood pressure ≥ 80 mmHg;
  2. Diabetes: ① Typical symptoms of diabetes, and any of the following: ② Random blood glucose ≥ 11.1 mmol/L; ③ Fasting blood glucose (FPG) ≥ 7.0 mmol/L; ④ OGTT 2-hour postprandial blood glucose ≥ 11.1 mmol/L; ⑤ HbA1c ≥ 6.5%;
  3. Obesity and overweight: Body mass index (BMI) ≥ 24 kg/m²;
  4. Dyslipidemia: At least one of the following lipid indicators is abnormal: ① Total cholesterol (TC) ≥ 6.2 mmol/L; ② Low-density lipoprotein cholesterol (LDL-C) ≥ 4.1 mmol/L; ③ High-density lipoprotein cholesterol (HDL-C) \< 1.0 mmol/L; ④ Triglyceride (TG) ≥ 2.3 mmol/L; ⑤ Lipoprotein(a) ≥ 30 mg/dL;
  5. Hyperuricemia: The fasting blood uric acid levels on two different days were \> 420 μmol/L (7 mg/dL) in men and \> 360 μmol/L (6 mg/dL) in women.

Exclusion Criteria:

* Patients unable to provide informed consent.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Sun Yat-sen Univerity — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Xiaodong Zhuang

Conditions: Cardiometabolic Diseases, all-cause mortality, Cardiovascular death, Major adverse cardiovascular events