Real-World Cohort Study of Cardiopulmonary Function in Chinese Patients With Cardiovascular Disease: CPET Evaluation and Five-Year Prognostic Follow-Up Based on a Multicenter Structured Data Platform
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200,000
- 试验地点
- 2
- 主要终点
- Characteristics of CPET parameters across different cardiovascular diseases.
研究概览
简要总结
The goal of this observational study is to observe the characteristics of cardiopulmonary exercise testing (CPET) parameters in patients across different cardiovascular diseases and to evaluate the predictive value of multiparameter cardiopulmonary indices for 5-year major adverse cardiovascular events (MACE).
详细描述
To investigate the CPET characteristics in patients with various cardiovascular diseases (including acute myocardial infarction, heart failure, cardiomyopathy, valvular heart disease, coronary artery disease, and perioperative cardiac surgery), with annual follow-up of major adverse cardiovascular events (MACE) for five years, and to establish the predictive value of combined CPET parameters for MACE in this population
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-80 years,
- •Ability to comprehend and provide written informed consent.
排除标准
- •Comorbid severe conditions (e.g., recent acute myocardial infarction, unstable angina, uncontrolled arrhythmias, severe aortic coarctation or descending aortic aneurysm, acute myocarditis or pericarditis, acute congestive heart failure, acute respiratory failure, resting oxygen saturation <93%, recent arterial or pulmonary embolism, pulmonary edema).
- •Conditions potentially exacerbated by exercise (e.g., acute cardiac insufficiency, exercise-induced asthma, epilepsy).
- •Physical disability due to musculoskeletal or neuromuscular disorders.
- •Pregnancy or lactation.
- •Patients deemed unsuitable for participation by the investigator.
研究组 & 干预措施
cardiovascular disease patient with MACE
cardiovascular disease patient with MACE（Cardiac death, unplanned revascularization, cardiac readmission, non-fatal myocardial infarction, and stroke）
cardiovascular disease patient without MACE
结局指标
主要结局
Characteristics of CPET parameters across different cardiovascular diseases.
时间窗: After enrollment
Cardiopulmonary exercise testing (CPET) was performed using exercise cardiopulmonary testing systems from VYAIRE (Germany) and SCHILLER (Switzerland). A symptom-limited maximal exercise test with a 1-minute ramp incremental protocol (Ramp protocol) was adopted, designed to complete the workload test within 8-12 minutes according to the incremental power calculation formula. The incremental workload was calculated as follows: Unloaded VO₂ (ml/min) per minute = 150 + (6 × body weight) Predicted peak VO₂max (ml/min) per minute for males = (height in cm - age in years) × 20 Predicted peak VO₂max (ml/min) per minute for females = (height in cm - age in years) × 14 Incremental power per minute = (predicted peak VO₂max - unloaded VO₂)/100 During exercise, real-time cardiopulmonary parameters were collected, including peak oxygen uptake (VO₂peak), anaerobic threshold (AT), maximal cycling workload, respiratory rate, minute ventilation (VE), and ventilatory efficiency, among others.
Incidence of 5-year MACE
时间窗: from enrollment to 5 years post-enrollment
MACE (cardiovascular death, unplanned repeat revascularization, cardiac rehospitalization, non-fatal myocardial infarction, stroke)
次要结局
- Incidence of individual events of MACE per year (incidence of cardiac death, unplanned rereconstitution, cardiac rehospitalization, nonfatal myocardial infarction, and stroke)(yearly for 5 years (Year 1/2/3/4/5 from enrollment))
研究者
Huan Ma
Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation
Guangdong Provincial People's Hospital