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Clinical Trials/NCT06894095
NCT06894095RecruitingNot Applicable

Dongzong Cardiovascular Bio-imaging Registry Study

Jinling Hospital, China1 site in 1 country50,000 target enrollmentStarted: May 24, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50,000
Locations
1
Primary Endpoint
Major adverse cardiovascular events

Study Overview

Brief 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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor
Jinling Hospital, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhang longjiang,MD

Principal Investigator (PI): Zhang Longjiang; Co-PI: Tang Chunxiang

Jinling Hospital, China

Study Sites (1)

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