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Recruiting NCT06894095

Dongzong Cardiovascular Bio-imaging Registry Study

Observational Cardiovascular Diseases Multi-omics Living Environments Pulmonary-cardiovascular Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, Multi-omics, Living Environments, Pulmonary-cardiovascular Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • Major adverse cardiovascular events [Time frame: Once a year until the tenth year]
Secondary outcome measures (11)
  • Invasive coronary angiography [Time frame: Once a year until the tenth year]
  • Coronary revascularization [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 [Time frame: Once a year until the tenth year]
  • Coronary plaque progression, regression, formation [Time frame: Once every two years at least, until the tenth year]
  • Changes in functional small airways, pulmonary small vessels and emphysema volume [Time frame: Once every two years at least, until the tenth year]
  • Emerging disease, regression or progression of established disease [Time frame: Once a year until the tenth year]
  • Medication adjustment [Time frame: Once a year until the tenth year]
  • Medication regularly [Time frame: once a year till the tenth year]
  • Smoking, alcohol consumption, dietary habits, physical activity, symptoms, life quality [Time frame: Once every five years until the tenth year]
  • Anxiety and cognition [Time frame: Once every five years until the tenth year]
  • Adverse reactions to iodinated contrast agents [Time frame: Within 1 hour and between 1 hour to 1 week after after contrast agent injection]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Longjiang Zhang — Nanjing

Identifiers

NCT: NCT06894095 · 2023NZKY-018-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗