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RecruitingNCT06894095DAILYUpdated Mar 25, 2025

Dongzong Cardiovascular Bio-imaging Registry Study

An observational study in Cardiovascular Diseases, Multi-omics and Living Environments, sponsored by Jinling Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Jinling Hospital, China · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Ages
18 Years and older
Sex
All
01

Study summary

The DAILY project is a large-scale, multicenter, prospective initiative designed to establish a comprehensive bio-imaging database that integrates multidimensional data, including living environments, psychosocial and cognitive assessments, advanced lung and cardiovascular imaging, multi-omics profiles, clinical medication and surgical records, and health outcomes. Leveraging this extensive, multiscale dataset, the project aims to elucidate the intricate interplay between genetic biology and environmental factors in driving downstream biological alterations, thereby shaping lung and cardiovascular structural and functional phenotypes, and ultimately influencing the onset and progression of cardiovascular diseases (CVD). Through a systematic exploration and understanding of this complex network, the project seeks to identify critical intervention points and develop innovative strategies for the prevention and management of CVD.

Read the detailed description

Cardiovascular diseases (CVD) are the leading cause of global mortality, representing a major public health challenge that threatens life and health both presently and in the foreseeable future. The reduction of modifiable risk factors remains a powerful and essential strategy, however, the application of clinical risk scores has demonstrated limited efficacy in significantly reducing cardiovascular events. In recent years, the emergence of multi-omics has provided novel insights into the prevention and management of CVD, offering opportunities to deeply understand its drivers at the genetic and biological levels. Nevertheless, the clinical utility and widespread adoption of these approaches face significant challenges, primarily due to two critical factors: First, multi-omics datasets, particularly GWAS datasets, exhibit a pronounced Eurocentric bias; second, the vast array of multi-omics indicators cannot be effectively integrated with living environments and diseases to construct a comprehensive biological network, thereby hindering the deciphering of key biological pathways and biomarkers for clinical translation. To address these limitations, we propose leveraging modern imaging technologies as an "intermediate bridge", because when critical biological pathways are triggered by genes, environmental factors, or their interactions, the earliest manifestations are impairments in cardiac and pulmonary structure and function (intermediate phenotypes). Accordingly, the DAILY project aims to enroll 50,000 participants across China, stratified by economic levels, geography, and living environments, to establish a high-quality bio-imaging database. This database will encompass: (1) advanced imaging-derived anatomical and functional phenotypes, along with precise hemodynamic measurements; (2) extensive multi-omics indicators, particularly genomics and downstream transcriptomics, proteomics, and metabolomics; (3) comprehensive living environments, psychological and cognitive date, and longitudinal health outcome; and (4) clinical medication and surgical records, along with other detailed clinical information.

Currently, there is a lack of a high-quality bio-imaging data platform based on the Chinese population to construct a complete pathway from genes/environment to disease, thereby enabling the development of promising strategies for CVD prevention and management.

02

Conditions studied

  • Cardiovascular Diseases
  • Multi-omics
  • Living Environments
  • Pulmonary-cardiovascular Imaging
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Consecutively enrolled individuals scheduled for coronary CTA, including those with known or suspected coronary artery disease (CAD) or individuals undergoing screening

Inclusion criteria

  • Aged ≥18 years
  • Coronary CT angiography performed
  • Informed consent acquired

Exclusion criteria

Exclusion Criteria:

  • Unable to complete the follow-up
  • Serious chronic kidney disease (eGFR\< 30 ml/min/1.73 m2)
  • Serious liver disease or dysfunction (chronic active hepatitis and cirrhosis, or aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal)
  • Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc.
  • Suspected or known infectious diseases, such as hepatitis B virus (HBV), human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), and Treponema pallidum (syphilis), etc.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular events

    Occurrence of major adverse cardiovascular events at prespecified follow-up ( once a year till the thirty year), defined as a composite of all-cause death, non-fatal myocardial infarction, unplanned revascularization , and hospitalization for unstable angina. Death cases consist of cardiovascular death, non-cardiovascular death, and undetermined cause of death.

    Time frame: Once a year until the tenth year

Secondary outcomes

  1. Invasive coronary angiography

    Including invasive coronary angiography, diagnostic invasive coronary angiography with revascularization, and invasive coronary angiography without obstructive coronary disease (\> 70% or \>50% diameter stenosis)

    Time frame: Once a year until the tenth year

  2. Coronary revascularization

    Coronary artery bypass grafting, percutaneous coronary interventions

    Time frame: Once a year until the tenth year

  3. Cardiovascular death, heart failure, atrial fibrillation, non-fatal MI, non-fatal stroke, unplanned revascularization, hospitalization for unstable angina

    Cardiovascular death, heart failure, atrial fibrillation, non-fatal MI, non-fatal stroke, unplanned revascularization, hospitalization for unstable angina

    Time frame: Once a year until the tenth year

  4. Coronary plaque progression, regression, formation

    Changes in the degree of coronary artery stenosis or plaque volume, or coronary plaque formation, or the volume, characteristics, and composition of high-risk plaques will be observed in participants with serial coronary CTA

    Time frame: Once every two years at least, until the tenth year

  5. Changes in functional small airways, pulmonary small vessels and emphysema volume

    Patients undergoing serial chest CT scans were followed up to monitor changes in quantitative CT parameters, including emphysema volume, functional small airway volume, normal lung parenchyma volume and its percentage of total lung volume, as well as quantitative pulmonary small vessel metrics: the number of pulmonary vessels located at 6, 9, 12, 15, 18, 21, and 24 mm from the pleura across the entire lung, and the number of small vessels with a cross-sectional area less than 5 mm², or other relevant parameters

    Time frame: Once every two years at least, until the tenth year

  6. Emerging disease, regression or progression of established disease

    Emerging diseases across various systems, such as metabolic disorders (e.g., hypertension, hyperlipidemia, hyperglycemia), cardiovascular diseases (e.g., hypertrophic cardiomyopathy, myocarditis), peripheral vascular diseases (e.g., deep vein thrombosis, arteritis), respiratory diseases (e.g., COPD, pulmonary hypertension), neurological disorders (e.g., dementia, Alzheimer's disease), malignancies (e.g., lung cancer, breast cancer), and diseases of other systems, will be documented. Additionally, the progression or regression of established disease will be recorded, for example, the development of diabetic retinopathy following the worsening of diabetes or the regression of impaired glucose tolerance, as well as the early surgical treatment of lung cancer or its recurrence in advanced stages.

    Time frame: Once a year until the tenth year

  7. Medication adjustment

    Medication adjustment includes the increase or decrease of the drug dose and the new addition or discontinuation of medications after CCTA examination.

    Time frame: Once a year until the tenth year

  8. Medication regularly

    Taking medication regularly defined as the total number of days within the final month of a year during which established medication is taken (including Antiplatelet agents, Antihypertensive agents, Hypoglycemic agents, Lipid-lowering agents, Anti-inflammatory agents and and other agents).

    Time frame: once a year till the tenth year

  9. Smoking, alcohol consumption, dietary habits, physical activity, symptoms, life quality

    A questionnaire-based follow-up that will mainly focus on smoking, alcohol consumption, dietary habits, physical activity, symptoms, and life quality (EQ-5D)

    Time frame: Once every five years until the tenth year

  10. Anxiety and cognition

    A questionnaire-based follow-up that will mainly focus on anxiety and cognition

    Time frame: Once every five years until the tenth year

  11. Adverse reactions to iodinated contrast agents

    Acute adverse and late adverse reactions to iodinated contrast agents

    Time frame: Within 1 hour and between 1 hour to 1 week after after contrast agent injection

07

Study locations

1 of 1 sites recruiting
  • Longjiang Zhang
    Nanjing, Jiangsu 210002, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06894095
Lead sponsor
Jinling Hospital, China
Responsible party
Zhang longjiang,MD (Principal Investigator (PI): Zhang Longjiang; Co-PI: Tang Chunxiang, Jinling Hospital, China) — Principal investigator
First posted
Mar 25, 2025
Start date
May 24, 2023
Primary completion
Mar 31, 2028 (estimated)
Completion
May 31, 2038 (estimated)
Last update
Mar 25, 2025

Study contacts

Longjiang Zhang, MD
Contact
kevinzhlj@163.com
13405833167
Chunxiang Tang, PhD
Contact
tangcx@nju.edu.cn
13814096738
Longjiang Zhang, MD
principal investigator · Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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