- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06972784
- Original Trial
Xiangya Cardiopulmonary Health and Disease Cohort (XY-CPHDC)
Study Overview
Status
Detailed Description
1.2.1 Study objective
- 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.
- Explore the core indicators related to cardiopulmonary hypofunction and disease risk, and construct a joint stratification system of cardiopulmonary function.
- 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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: yuan zhang, PhD
- Phone Number: 86-0731-84327029
- Email: zhangyuan9194@163.com
Study Locations
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Hunan
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Changsha, Hunan, China, 457500
- Recruiting
- Xiangya Hospital, Central South University Affiliated
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Contact:
- yuan zhang, PhD
- Phone Number: 86-0731-84327029
- Email: zhangyuan9194@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
I1 Inclusion and exclusion criteria for retrospective cohorts 1) Inclusion criteria:
- 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.
2)Exclusion criteria
- 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).
2.1.2 Inclusion and exclusion criteria for prospective cohort
1)Inclusion criteria
- 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).
2) Exclusion Criteria.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Retrospective cohort
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Prospective cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Death due to any cause or specific cause
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Through study completion, an average of 3 years
|
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Hospitalization Costs
Time Frame: Through study completion, an average of 3 years
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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).
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Through study completion, an average of 3 years
|
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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.)
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Through study completion, an average of 3 years
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Number of participants with respiratory diseases or events
Time Frame: Through study completion, an average of 3 years
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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.)
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Through study completion, an average of 3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022YFC3601001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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