NCT07308314

Brief Summary

This study aims to establish the first county-level, population-based prospective cohort in Taining County, Fujian Province, China. The cohort will include at least 20,000 residents aged 18 years or older. The project will systematically collect questionnaires, physical measurements, laboratory tests, imaging data, and biological samples to build a multi-dimensional health database and biobank. Through 3-year follow-up, the study seeks to reveal the epidemiological patterns and risk factors of chronic diseases, characterize the natural course of multimorbidity and aging syndromes, and develop a comprehensive chronic disease management model suitable for rural and mountainous regions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Aug 2025

Typical duration 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 Progress26%
Aug 2025Jul 2028

Study Start

First participant enrolled

August 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Chronic Disease ManagementProspective CohortHypertensionDiabetes MellitusDyslipidemiaCardiovascular DiseaseFrailtySarcopeniaAgingHealthy Aging

Outcome Measures

Primary Outcomes (1)

  • Incidence of Major Adverse Cardiovascular Events (MACE)

    Composite outcome including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Events will be ascertained through active follow-up and confirmed using medical records and hospital discharge summaries.

    Up to 36 months

Secondary Outcomes (7)

  • Incidence of Cardiovascular and Cerebrovascular Events

    Up to 36 months

  • Heart Failure-Related Rehospitalization Rate

    Up to 36 months

  • Bleeding Events

    Up to 36 months

  • Health Economics Outcomes

    Up to 36 months

  • Cognitive Function Outcomes

    Baseline and annual follow-up (Year 1-3)

  • +2 more secondary outcomes

Study Arms (1)

Taining County Resident Cohort

A community-based cohort of ≥20,000 adult residents (aged 18 years and older) living in Taining County, Fujian Province, China. Participants will undergo baseline assessments including questionnaires, physical examinations, laboratory tests, imaging, and biospecimen collection. Annual follow-up (active and passive) will be conducted for 3 years to record incidence of chronic diseases, functional status, and aging-related outcomes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of community-dwelling adult residents of Taining County, a mountainous region in Fujian Province, China. Eligible participants are men and women aged 18 years and older who have lived in the county for at least 6 months and are expected to remain for the next 3 years. A total of at least 20,000 participants will be enrolled at baseline through community-based recruitment and household registration systems. The population reflects the demographic and health characteristics of a rural county with a relatively high proportion of older adults and a growing burden of chronic diseases such as hypertension, diabetes, and cardiovascular disease.

You may qualify if:

  • Age ≥18 years, male or female.
  • Resident of Taining County for ≥6 months and expected to remain in the county for at least the next 3 years.
  • Full civil capacity and able to understand study procedures.
  • Willing to voluntarily participate and provide written informed consent.
  • Able to complete baseline survey and follow-up visits.

You may not qualify if:

  • Refusal to sign informed consent.
  • Severe psychiatric disorders or cognitive impairment preventing participation.
  • End-stage disease with expected survival \<1 year.
  • Long-term migrants (≥6 months per year outside the county), unable to guarantee follow-up.
  • Participation in other clinical studies that may interfere with this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350011, China

RECRUITING

Related Publications (12)

  • Chen L, Li X, Lv Y, Tan X, Zhong VW, Rong S, Liu G, Liu L. Physical frailty, adherence to ideal cardiovascular health and risk of cardiovascular disease: a prospective cohort study. Age Ageing. 2023 Jan 8;52(1):afac311. doi: 10.1093/ageing/afac311.

    PMID: 36626327BACKGROUND
  • Hu L, Li J, Tang Z, Gong P, Chang Z, Yang C, Ma T, Jiang S, Yang C, Zhang T. How does biological age acceleration mediate the associations of obesity with cardiovascular disease? Evidence from international multi-cohort studies. Cardiovasc Diabetol. 2025 May 14;24(1):209. doi: 10.1186/s12933-025-02770-0.

    PMID: 40369582BACKGROUND
  • Global Cardiovascular Risk Consortium; Magnussen C, Ojeda FM, Leong DP, Alegre-Diaz J, Amouyel P, Aviles-Santa L, De Bacquer D, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Brenner H, Carrillo-Larco RM, de Lemos J, Dobson A, Dorr M, Donfrancesco C, Drygas W, Dullaart RP, Engstrom G, Ferrario MM, Ferrieres J, de Gaetano G, Goldbourt U, Gonzalez C, Grassi G, Hodge AM, Hveem K, Iacoviello L, Ikram MK, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Koenig W, Kontsevaya A, Kuulasmaa K, Lackner KJ, Leistner DM, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Nalini M, Nambi V, Ninomiya T, Oppermann K, d'Orsi E, Pajak A, Palmieri L, Panagiotakos D, Perianayagam A, Peters A, Poustchi H, Prentice AM, Prescott E, Riserus U, Salomaa V, Sans S, Sakata S, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw JE, Simons LA, Soderberg S, Tamosiunas A, Thorand B, Tunstall-Pedoe H, Twerenbold R, Vanuzzo D, Veronesi G, Waibel J, Wannamethee SG, Watanabe M, Wild PS, Yao Y, Zeng Y, Ziegler A, Blankenberg S. Global Effect of Modifiable Risk Factors on Cardiovascular Disease and Mortality. N Engl J Med. 2023 Oct 5;389(14):1273-1285. doi: 10.1056/NEJMoa2206916. Epub 2023 Aug 26.

    PMID: 37632466BACKGROUND
  • Moturi S, Ghosh-Choudhary SK, Finkel T. Cardiovascular disease and the biology of aging. J Mol Cell Cardiol. 2022 Jun;167:109-117. doi: 10.1016/j.yjmcc.2022.04.005. Epub 2022 Apr 11.

    PMID: 35421400BACKGROUND
  • Liberale L, Badimon L, Montecucco F, Luscher TF, Libby P, Camici GG. Inflammation, Aging, and Cardiovascular Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Mar 1;79(8):837-847. doi: 10.1016/j.jacc.2021.12.017.

    PMID: 35210039BACKGROUND
  • Hu C. Prevention of cardiovascular disease for healthy aging and longevity: A new scoring system and related "mechanisms-hallmarks-biomarkers". Ageing Res Rev. 2025 May;107:102727. doi: 10.1016/j.arr.2025.102727. Epub 2025 Mar 15.

    PMID: 40096912BACKGROUND
  • da Silva PFL, Schumacher B. Principles of the Molecular and Cellular Mechanisms of Aging. J Invest Dermatol. 2021 Apr;141(4S):951-960. doi: 10.1016/j.jid.2020.11.018. Epub 2021 Jan 29.

    PMID: 33518357BACKGROUND
  • Moqri M, Herzog C, Poganik JR; Biomarkers of Aging Consortium; Justice J, Belsky DW, Higgins-Chen A, Moskalev A, Fuellen G, Cohen AA, Bautmans I, Widschwendter M, Ding J, Fleming A, Mannick J, Han JJ, Zhavoronkov A, Barzilai N, Kaeberlein M, Cummings S, Kennedy BK, Ferrucci L, Horvath S, Verdin E, Maier AB, Snyder MP, Sebastiano V, Gladyshev VN. Biomarkers of aging for the identification and evaluation of longevity interventions. Cell. 2023 Aug 31;186(18):3758-3775. doi: 10.1016/j.cell.2023.08.003.

    PMID: 37657418BACKGROUND
  • Nash DB. The Future of Chronic Disease Management. Popul Health Manag. 2023 Aug;26(S1):S2-S3. doi: 10.1089/pop.2023.0128. No abstract available.

    PMID: 37603800BACKGROUND
  • Elendu C, Elendu RC, Enyong JM, Ibhiedu JO, Ishola IV, Egbunu EO, Meribole ES, Lawal SO, Okenwa CJ, Okafor GC, Umeh ED, Mutalib OO, Opashola KA, Fatoye JO, Awotoye TI, Tobih-Ojeanelo JI, Ramon-Yusuf HI, Olanrewaju A, Afuh RN, Adenikinju J, Amosu O, Yusuf A. Comprehensive review of current management guidelines of chronic kidney disease. Medicine (Baltimore). 2023 Jun 9;102(23):e33984. doi: 10.1097/MD.0000000000033984.

    PMID: 37335639BACKGROUND
  • Chan SW. Chronic Disease Management, Self-Efficacy and Quality of Life. J Nurs Res. 2021 Feb 1;29(1):e129. doi: 10.1097/JNR.0000000000000422. No abstract available.

    PMID: 33427791BACKGROUND
  • Halpin DMG, Criner GJ, Papi A, Singh D, Anzueto A, Martinez FJ, Agusti AA, Vogelmeier CF. Global Initiative for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease. The 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2021 Jan 1;203(1):24-36. doi: 10.1164/rccm.202009-3533SO.

    PMID: 33146552BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

15 mL fasting venous blood collected in the morning after an overnight fast. Used for routine hematology, biochemistry, platelet aggregation, BNP, CRP, and bone turnover markers. Aliquots will also be stored for future analyses. All biospecimens will be processed and stored according to standardized operating procedures. A biobank will be established at the county hospital and collaborating institutions to support future multi-omics and public health research.

MeSH Terms

Conditions

Chronic DiseaseHypertensionDiabetes MellitusDyslipidemiasFrailtySarcopeniaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Dajun Chai, MD

    First Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chief Physician, Department of Cardiology

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

December 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data, including demographic information, clinical characteristics, imaging parameters ECG data, laboratory test results, biospecimen profiles and follow-up outcomes, will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
IPD will be made available beginning 24 months after the primary study completion date and remain accessible for up to 24 months.
Access Criteria
Qualified researchers with a scientifically sound proposal may request access to the data. Requests will be evaluated by the study steering committee. Approved users must sign a data use agreement ensuring compliance with privacy, ethical, and scientific standards.
More information

Locations