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NCT Number: NCT06894095

Dongzong Cardiovascular Bio-imaging Registry Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: Once a year until the tenth year

    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.

Secondary outcomes

  1. Invasive coronary angiography

    Time frame: Once a year until the tenth year

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

  2. Coronary revascularization

    Time frame: Once a year until the tenth year

    Coronary artery bypass grafting, percutaneous coronary interventions

  3. 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

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

  4. Coronary plaque progression, regression, formation

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

    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

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

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

    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

  6. Emerging disease, regression or progression of established disease

    Time frame: Once a year until the tenth year

    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.

  7. Medication adjustment

    Time frame: Once a year until the tenth year

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

  8. Medication regularly

    Time frame: once a year till the tenth year

    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).

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

    Time frame: Once every five years until the tenth year

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

  10. Anxiety and cognition

    Time frame: Once every five years until the tenth year

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

  11. Adverse reactions to iodinated contrast agents

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

    Acute adverse and late adverse reactions to iodinated contrast agents

Study contacts

Contact information is provided by the study sponsor or research team.

Chunxiang Tang, PhD

CONTACT

[email protected]

13814096738

Longjiang Zhang, MD

CONTACT

[email protected]

13405833167

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Acronym: DAILY

Important dates

Study start
2023
Primary completion
2028
Study completion
2038
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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