NCT07038083

Brief Summary

This study is a single-center, historical prospective cohort study including patients diagnosed with metabolic cardiovascular disease, including hypertension, diabetes, obesity, dyslipidemia, hyperuricemia. The primary outcome of the study is all-cause death and cardiovascular death, and the secondary outcome is major adverse cardiovascular events. We aim to measure associations of established or suspected cardiometabolic disease (CMD) risk factors and cardiovascular disease outcomes in a real-world representative cohort.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
215mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Jan 2014Jan 2044

Study Start

First participant enrolled

January 1, 2014

Completed
11.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
18.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2044

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2044

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

30 years

First QC Date

June 18, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

Cardiometabolic Diseasesall-cause mortalityCardiovascular deathMajor adverse cardiovascular events

Outcome Measures

Primary Outcomes (2)

  • all-cause mortality

    Death due to any cause after enrollment

    Through study completion, an average of 5 years

  • Cardiovascular death

    Death caused by cardiac causes

    Through study completion, an average of 5 years

Secondary Outcomes (1)

  • Major adverse cardiovascular events

    Through study completion, an average of 5 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with cardiometabolic diseases during hospitalization were enrolled.

You may qualify if:

  • Patients over 18 years old;
  • Patients with clinical diagnosis of metabolic cardiovascular disease, including hypertension, diabetes, obesity, dyslipidemia, hyperuricemia.
  • 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;
  • 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%;
  • Obesity and overweight: Body mass index (BMI) ≥ 24 kg/m²;
  • 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;
  • 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.

You may not qualify if:

  • Patients unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen Univerity

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2044

Study Completion (Estimated)

January 1, 2044

Last Updated

June 26, 2025

Record last verified: 2025-06

Locations