NCT06972784

Brief Summary

Xiangya Cardiopulmonary Health and Disease Cohort (XY-CPHDC) is a non-intervention study grounded in real-world data. It is designed as a bidrectional clinical cohort combined retrospective and prospective design, in order to evaluate cardiopulmonary function systematically and holistically, integrate physiology and medical theory, and explore the changing pattern of the cardiopulmonary under different health states. Cardiovascular System and Respiratory System are closely linked and interdependent physiological systems, and they play a vital role in maintaining normal life activities in the human body. Patients with cardiopulmonary disease often have conspicuous comorbidity characteristics, however, current measurements of cardiopulmonary function indicators are mostly limited to the assessments of single organ. This pattern of subspecialty care leads to deficiencies in the recognition of cardiopulmonary synergy dysfunction, and there is an urgent need for a more comprehensive and systematic approach to assessment. This study plans to construct a cardiopulmonary holistic assessment cohort, aiming at comprehensively and systematically reveal the intrinsic connection between the cardiopulmonary function in different scenarios, such as resting, exercise, and sleep, to deeply explore the core indicators of cardiopulmonary holistic function, to construct a joint stratification system of cardiopulmonary function, and to map cardiopulmonary comorbidity spectrum, so that they can accurately guide the diagnosis of the disease, the prognostic prediction and the intervention strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jun 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2025Dec 2035

First Submitted

Initial submission to the registry

May 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

July 2, 2025

Status Verified

December 1, 2024

Enrollment Period

10.5 years

First QC Date

May 7, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

Respiratory function tests,Heart Function Tests,Cardiopulmonary function

Outcome Measures

Primary Outcomes (1)

  • Death event

    Death due to any cause or specific cause

    From participants agreed to participate in this study until the date of death from any or specific cause or the end of the study, whichever came first, assessed up to 10 years

Secondary Outcomes (4)

  • Life quality as measured by the 12-item short form health survey (SF-12).

    Through study completion, an average of 3 years

  • Hospitalization Costs

    Through study completion, an average of 3 years

  • Number of participants with cardiometabolic diseases or events

    Through study completion, an average of 3 years

  • Number of participants with respiratory diseases or events

    Through study completion, an average of 3 years

Study Arms (2)

Retrospective cohort

Prospective cohort

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Xiangya Cardiopulmonary Health and Disease Cohort( XY-CPHDC) is a bidirectional clinical cohort integrating retrospective and prospective designs to systematically evaluate cardiopulmonary functional synergy

You may not qualify if:

  • Patients were either treated or hospitalized in the physical examination center, outpatient and emergency clinic in the Xiangya Hospital of Central South University from January 2010 to April 2025.
  • Completion of cardiac function (e.g., echocardiography) and pulmonary function (e.g., pulmonary function test) assessment, with an interval of no more than 1 year between the two.
  • Those who had complete clinical diagnostic and therapeutic information (e.g., medical history, medication records, laboratory test results, imaging reports) except for the cardiopulmonary function test report.
  • Patients with complete loss of cardiopulmonary function test reports or key data (e.g., VO2peak, FEV1/FVC, LVEF).
  • Patients with loss of key clinical diagnostic and treatment data (e.g., medical history, medication records, laboratory test results).
  • Patients who have been included in the retrospective cohort.
  • Voluntarily signed informed consent form to participate in long-term follow-up for ≥3 years.
  • Able to complete the baseline assessment of the prospective cohort (including cardiopulmonary function retesting, questionnaires, etc.).
  • Stable conditions for follow-up (e.g., living in the local area, available valid contact information, no plans to move in the short term or go out for a long period of time).
  • Patients who have been excluded from the retrospective cohort or for whom key data are missing.
  • With severe cognitive impairment, psychiatric disease or verbal communication disorder, unable to cooperate with follow-up and data collection.
  • Expected survival time \<3 years (e.g., advanced malignancy, end-stage cardiopulmonary failure, etc.).
  • Incomplete cardiopulmonary function or other clinical data during the baseline assessment.
  • Those who plan to participate in other interventional clinical trials that may interfere with the assessment of cardiopulmonary function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital, Central South University Affiliated

Changsha, Hunan, 457500, China

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

July 2, 2025

Record last verified: 2024-12

Locations