the Real-world Data of Risk Factor and Its Prognosis in PREmature Coronary ARtery DIseAse Study (PRE-CARDIA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 主要终点
- International physical activity questionnaire
研究概览
简要总结
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]:
- Do patients with premature coronary heart disease have accelerated biological aging?
- What is the prognosis of accelerated biological aging in patients with premature coronary heart disease?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- 未提供
结局指标
主要结局
International physical activity questionnaire
时间窗: 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
时间窗: Up to 8 weeks.
Record participants' daily exercise, more objective than questionnaires.
Cardiopulmonary test
时间窗: Up to 8 weeks.
Representation of extreme and sub-extreme motion.
Glucose
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Xiao-dong Zhuang
Professor
First Affiliated Hospital, Sun Yat-Sen University