Xiangya Cardiopulmonary Health and Disease Cohort (XY-CPHDC)

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.

Study Overview

Detailed Description

1.2.1 Study objective

  1. Construct a cardiopulmonary holistic assessment cohort covering the full range of resting-exercise-sleep scenarios and encompassing non-cardiopulmonary disease-- cardiopulmonary hypofunction--cardiopulmonary disease populations in the longitudinal development of time.
  2. Explore the core indicators related to cardiopulmonary hypofunction and disease risk, and construct a joint stratification system of cardiopulmonary function.
  3. Map the cardiopulmonary comorbidity spectrum and describe its functional characteristics using the cardiopulmonary holistic assessment cohort, and analyze the impact of comorbidity patterns on patient's long-term prognosis and clinical outcomes.

1.2.2 Study type Bidirectional cohort design Retrospective cohort: Integrate historical hospital data(e.g., electronic medical records, imaging reports, cardiopulmonary function test records) and select the study population according to the inclusion and exclusion criteria.

Prospect cohort: patients from the retrospective cohort were screened to meet the study requirements and agreed to participate in subsequent studies for long-term follow-up(≥3years) and dynamic monitoring of cardiopulmonary function changes, 1.2.3 study content Building a cardiopulmonary cohort: build a full range of clinical cohort covering resting, exercise, and sleep scenarios with non-diseased, hypofunctional and cardiopulmonary disease populations, integrating retrospective data analysis and prospective follow-up monitoring to comprehensively reflect the cardiopulmonary performance of individuals in different physiological states, and laying the data foundation for subsequent analyses.

Constructing a joint stratification system for cardiopulmonary function: based on the data collected from the cardiopulmonary holistic assessment cohort, further in-depth feature extraction of cardiopulmonary function indicators is performed, and key indicators capable of predicting cardiopulmonary function decline and disease risk are screened out through data mining and dynamic monitoring, integrating the core indicators into a multidimensional risk indicator system, and stratifying patients by using a clustering method or based on a risk score, dividing low, medium and high risk groups, and realize the dynamic update of the stratification model.

Characterizing the cardiopulmonary comorbidity spectrum: Using the constructed cardiopulmonary cohort and the stratification system, we will deeply reveal the functional characteristics of cardiopulmonary comorbidity, analyze the functional changes and characteristics of patients with cardiopulmonary comorbidity in different scenarios (e.g., resting, exercising, or sleeping), and depict the characteristics of cardiopulmonary comorbidity spectrum; through the cardiopulmonary co-morbidity spectrum, we will deeply explore the interaction mechanism between the heart and the lungs in the progression of the disease, and analyze the impact of comorbidity on the prognosis and clinical outcomes of patients.

Study Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hunan
      • Changsha, Hunan, China, 457500
        • Recruiting
        • Xiangya Hospital, Central South University Affiliated
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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

Description

I1 Inclusion and exclusion criteria for retrospective cohorts 1) Inclusion criteria:

  1. 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.
  2. 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.
  3. 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.

2)Exclusion criteria

  1. Patients with complete loss of cardiopulmonary function test reports or key data (e.g., VO2peak, FEV1/FVC, LVEF).
  2. Patients with loss of key clinical diagnostic and treatment data (e.g., medical history, medication records, laboratory test results).

2.1.2 Inclusion and exclusion criteria for prospective cohort

1)Inclusion criteria

  1. Patients who have been included in the retrospective cohort.
  2. Voluntarily signed informed consent form to participate in long-term follow-up for ≥3 years.
  3. Able to complete the baseline assessment of the prospective cohort (including cardiopulmonary function retesting, questionnaires, etc.).
  4. 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).

2) Exclusion Criteria.

  1. Patients who have been excluded from the retrospective cohort or for whom key data are missing.
  2. With severe cognitive impairment, psychiatric disease or verbal communication disorder, unable to cooperate with follow-up and data collection.
  3. Expected survival time <3 years (e.g., advanced malignancy, end-stage cardiopulmonary failure, etc.).
  4. Incomplete cardiopulmonary function or other clinical data during the baseline assessment.
  5. Those who plan to participate in other interventional clinical trials that may interfere with the assessment of cardiopulmonary function.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Retrospective cohort
Prospective cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death event
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life quality as measured by the 12-item short form health survey (SF-12).
Time Frame: Through study completion, an average of 3 years
The seven situations of SF-12 include physical function, role limitations due to physical health or emotional problems, bodily pain, general health perceptions, vitality, and social function. The scoring criteria for the SF-12 scale is based on a percentage system, where higher scores indicate better quality of life
Through study completion, an average of 3 years
Hospitalization Costs
Time Frame: Through study completion, an average of 3 years
Direct medical costs during hospitalization, including medication, diagnostic tests, therapeutic procedures, nursing care, and bed fees.Single admission: from admission to discharge; Multiple admissions: cumulative costs until study completion.Costs are inflation-adjusted and reported in RMB (USD equivalents provided for cross-regional comparisons when applicable).
Through study completion, an average of 3 years
Number of participants with cardiometabolic diseases or events
Time Frame: Through study completion, an average of 3 years
The occurrence of cardiometabolic diseases or events (e.g. hypertension, heart failure, ACS and DM, etc.) are identified by self-report or their electronic health records and tests (e.g. blood pressure, blood glucose, lipids and hormone levels, echocardiogram, ECG etc.)
Through study completion, an average of 3 years
Number of participants with respiratory diseases or events
Time Frame: Through study completion, an average of 3 years
The occurrence of respiratory diseases or events (e.g. COPD and asthma, or hospitalization due to exacerbation etc.) are identified by self-report or their electronic health records and tests (e.g. lung function test parameters, etc.)
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

May 7, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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