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

N/AEnrolling By InvitationNCT07130968

Guangdong Provincial People's Hospital200,000 enrolled

Overview

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).

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

Study Type

OBSERVATIONAL

Enrollment

200,000

Conditions

MACE Cardiac Death Unplanned Repeat Revascularization Cardiac Rehospitalization Non-fatal Myocardial Infarction Stroke

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18-80 years, 2. Ability to comprehend and provide written informed consent. Exclusion Criteria: 1. 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). 2. Conditions potentially exacerbated by exercise (e.g., acute cardiac insufficiency, exercise-induced asthma, epilepsy). 3. Physical disability due to musculoskeletal or neuromuscular disorders. 4. Pregnancy or lactation. 5. Patients deemed unsuitable for participation by the investigator.

Outcomes

Primary Outcomes

Characteristics of CPET parameters across different cardiovascular diseases.

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.

Time frame: After enrollment

Incidence of 5-year MACE

MACE (cardiovascular death, unplanned repeat revascularization, cardiac rehospitalization, non-fatal myocardial infarction, stroke)

Time frame: from enrollment to 5 years post-enrollment

Secondary Outcomes

Incidence of individual events of MACE per year (incidence of cardiac death, unplanned rereconstitution, cardiac rehospitalization, nonfatal myocardial infarction, and stroke)

Time frame: yearly for 5 years (Year 1/2/3/4/5 from enrollment)