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

NCT07130968 | Enrolling By Invitation

• 1 other identifier: KY2025-499-04
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

Cardiopulmonary Exercise Testing; Cardiovascular Diseases; Major Adverse Cardiovascular Events (MACE); Prognosis; Exercise Capacity; Cardiorespiratory Fitness; Clinical Outcomes; Real-world Study

Outcome Measures

Primary Outcomes (2)

• 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.

  After enrollment

• Incidence of 5-year MACE

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

  from enrollment to 5 years post-enrollment

Secondary Outcomes (1)

• 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)

Other Outcomes (1)

• Incidence rate of adverse events during exercise

  During each exercise session and within 24 hours after exercise

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

China CardioVascular Disease Patient and healthy control group

You may qualify if:

• Age: 18-80 years,
• Ability to comprehend and provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Yuebei People's Hospital: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Gansu Provincial Hospital: collaborator
• Shenzhen Center for Chronic Disease Control: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Zhongshan Hospital Of Traditional Chinese Medicine: collaborator
• Zhengzhou Central Hospital: collaborator
• Dongguan Binhaiwan Central Hospital: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Related Publications (3)

• Shephard RJ, Balady GJ. Exercise as cardiovascular therapy. Circulation. 1999 Feb 23;99(7):963-72. doi: 10.1161/01.cir.99.7.963. No abstract available.

  PMID: 10027821 RESULT

• Fiuza-Luces C, Santos-Lozano A, Joyner M, Carrera-Bastos P, Picazo O, Zugaza JL, Izquierdo M, Ruilope LM, Lucia A. Exercise benefits in cardiovascular disease: beyond attenuation of traditional risk factors. Nat Rev Cardiol. 2018 Dec;15(12):731-743. doi: 10.1038/s41569-018-0065-1.

  PMID: 30115967 RESULT

• DeCato TW, Haverkamp H, Hegewald MJ. Cardiopulmonary Exercise Testing (CPET). Am J Respir Crit Care Med. 2020 Jan 1;201(1):P1-P2. doi: 10.1164/rccm.2011P1. No abstract available.

  PMID: 31891317 RESULT

Related Links

• websites associated with the cited references

MeSH Terms

Conditions

Death; Stroke; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Cardiology, Director of the Department of Cardiac Rehabilitation

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 30, 2035
• Study Completion (Estimated): December 30, 2035
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)