Dongzong Cardiovascular Bio-imaging Registry Study

NCT06894095 | Recruiting DMC

• 1 other identifier: 2023NZKY-018-02
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Once a year until the tenth year

Secondary Outcomes (11)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Longjiang Zhang

Nanjing, Jiangsu, 210002, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 10 ml of blood and 2 ml of saliva will be collected from each patient for the evaluation of conventional laboratory parameters. A portion of the sample will be analyzed for established clinical biomarkers, including lipid profiles, blood biochemistry, inflammatory markers, liver function, and renal function, among others. Additionally, the residual biological specimens will be employed for sequencing in various omics fields, including genomics, transcriptomics, proteomics, metabolomics, microbiomics, and other omics.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Longjiang Zhang, MD

  Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Longjiang Zhang, MD

CONTACT

13405833167; kevinzhlj@163.com

Chunxiang Tang, PhD

CONTACT

13814096738; tangcx@nju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI): Zhang Longjiang; Co-PI: Tang Chunxiang

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: May 24, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2038
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)