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Enrolling by invitation NCT07130968

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

— Observational MACE Cardiac Death Unplanned Repeat Revascularization Cardiac Rehospitalization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: MACE, Cardiac Death, Unplanned Repeat Revascularization, Cardiac Rehospitalization. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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).

Detailed description

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

Primary outcome measures

  • Characteristics of CPET parameters across different cardiovascular diseases. [Time frame: After enrollment]
  • Incidence of 5-year MACE [Time frame: from enrollment to 5 years post-enrollment]
Secondary outcome measures (1)
  • 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)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Guangdong Provincial People's Hospital — Guangzhou

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT07130968 · KY2025-499-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗