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

NCT06695182 | Active Not Recruiting DMC

• 1 other identifier: PRE-CARDIA study
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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. 1.Do patients with premature coronary heart disease have accelerated biological aging?
2. 2.What is the prognosis of accelerated biological aging in patients with premature coronary heart disease?

Conditions

Premature Coronary Heart Disease

Keywords

Premature coronary heart disease; Risk factor; aging

Outcome Measures

Primary Outcomes (9)

• International physical activity questionnaire

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

  Baseline.

• Accelerometer

  Record participants' daily exercise, more objective than questionnaires.

  Up to 8 weeks.

• Cardiopulmonary test

  Representation of extreme and sub-extreme motion.

  Up to 8 weeks.

• Glucose

  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.

  Up to 8 weeks.

• Hemoglobin A1c (HbA1c)

  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.

  Up to 8 weeks.

• Serum creatinine

  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.

  Up to 8 weeks.

• Lipid

  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).

  Up to 8 weeks.

• Serum uric acid

  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.

  Up to 8 weeks.

• Blood urea nitrogen

  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.

  Up to 8 weeks.

Secondary Outcomes (4)

• 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.

Study Arms (1)

premature coronary artery disease

Behavioral: physical activity

Interventions

physical activity BEHAVIORAL

premature coronary artery disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The definition of premature coronary heart disease is that the onset of coronary heart disease in men is ≤55 years old and that in women is ≤65 years old.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study adopts a single-center, one-arm and historical prospective cohort design, and plans to retrospectively collect the data of patients with metabolic cardiovascular diseases hospitalized in the Department of Cardiovascular Medicine of the First Affiliated Hospital of Sun Yat-sen University from January 2013 to now through the electronic medical record system.

You may qualify if:

• 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;

You may not qualify if:

• ·NA

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 19, 2024
• Study Start: October 1, 2013
• Primary Completion: November 1, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11