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Clinical Trials/NCT06695182
NCT06695182
Active, Not Recruiting
N/A

the Real-world Data of Risk Factor and Its Prognosis in PREmature Coronary ARtery DIseAse Study (PRE-CARDIA)

Sun Yat-sen University0 sites3,000 target enrollmentOctober 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Coronary Heart Disease
Sponsor
Sun Yat-sen University
Enrollment
3000
Primary Endpoint
International physical activity questionnaire
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this observational study is to explore the relationship between biological aging and long-term prognosis of patients with metabolic cardiovascular disease in premature coronary artery disease. The main question[s] it aims to answer [is/are]:

  1. Do patients with premature coronary heart disease have accelerated biological aging?
  2. What is the prognosis of accelerated biological aging in patients with premature coronary heart disease?
Registry
clinicaltrials.gov
Start Date
October 2013
End Date
March 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Xiao-dong Zhuang

Professor

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

  • Male or female inpatients over 18 years old in the Department of Cardiovascular Medicine;
  • Patients with one of the following metabolic cardiovascular diseases \[17\]: including diabetes, hypertension, coronary heart disease, heart failure, cerebral infarction, dyslipidemia, obesity and hyperuricemia;
  • Those who have corresponding inspection data so as to be able to calculate the biological age;
  • Obtaining oral informed consent or signing an informed consent form;

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

International physical activity questionnaire

Time Frame: Baseline.

The duration and form of exercise (low, moderate and high intensity) was reported in the form of recall, with higher scores representing more exercise.

Accelerometer

Time Frame: Up to 8 weeks.

Record participants' daily exercise, more objective than questionnaires.

Cardiopulmonary test

Time Frame: Up to 8 weeks.

Representation of extreme and sub-extreme motion.

Glucose

Time Frame: Up to 8 weeks.

Measurement of fasting blood glucose levels to evaluate changes in glucose metabolism and glycemic control. Fasting blood samples are collected in the morning following an 8- to 12-hour fast. Blood glucose concentration is measured in milligrams per deciliter (mg/dL) using a standardized laboratory analyzer to ensure accuracy and consistency.

Hemoglobin A1c (HbA1c)

Time Frame: Up to 8 weeks.

Measurement of Hemoglobin A1c (HbA1c) levels to evaluate long-term glycemic control over the past 2-3 months. HbA1c is measured as a percentage using a high-performance liquid chromatography (HPLC) method, providing an indication of average blood glucose levels.

Serum creatinine

Time Frame: Up to 8 weeks.

Measurement of serum creatinine levels to assess renal function and monitor potential changes over time. Serum creatinine is measured in milligrams per deciliter (mg/dL) using an enzymatic assay in a certified laboratory. This measurement serves as a key indicator of kidney function and is used to calculate the estimated glomerular filtration rate (eGFR) as an additional marker of renal health.

Lipid

Time Frame: Up to 8 weeks.

Measurement of lipid profile, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, to evaluate cardiovascular risk and lipid metabolism. Fasting blood samples are collected after an 8- to 12-hour fast and analyzed in a certified laboratory using enzymatic colorimetric assays. Results are expressed in milligrams per deciliter (mg/dL).

Serum uric acid

Time Frame: Up to 8 weeks.

Measurement of serum uric acid levels to assess purine metabolism and monitor for potential hyperuricemia. Serum uric acid is measured in milligrams per deciliter (mg/dL) using an enzymatic colorimetric method in a certified laboratory. This measure provides insight into kidney function and potential risk of gout.

Blood urea nitrogen

Time Frame: Up to 8 weeks.

Measurement of blood urea nitrogen (BUN) levels to evaluate kidney function and protein metabolism. BUN is measured in milligrams per deciliter (mg/dL) using an enzymatic assay in a certified laboratory, offering an indicator of renal health and nitrogen balance.

Secondary Outcomes

  • Center for Epidemiologic Studies Depression Scale (CES-D)(Up to 8 weeks.)
  • uroQol 5-Dimension 5-Level (EQ-5D-5L)(Up to 8 weeks.)
  • Multidimensional Sports Self-efficacy Scale (MSES)(Up to 8 weeks.)
  • Chinese self-efficacy for exercise scale (SEE-C)(Up to 8 weeks.)

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