Cardiovascular DiseasesDAILYNCT06894095
Dongzong Cardiovascular Bio-imaging Registry Study
An observational study of Cardiovascular Diseases and Multi-omics, run by Jinling Hospital, China at 3 sites in China.
Trial 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, psychosocial and cognitive assessments, panvascular and body imaging (fundus… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Multi-omics, Living Environments
- How many people
- 50,000 participants
- Where
- 3 sitesChina
- Study dates
- 24 May 2023to 31 May 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutively enrolled individuals scheduled for coronary CTA, including those with known or suspected coronary artery disease (CAD) or individuals undergoing screening
Who may be able to join
- Aged ≥18 years
- Coronary CT angiography performed
- Informed consent acquired
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Longjiang Zhang
Nanjing, Jiangsu, 210002
Longjiang Zhang, MD, 13405833167, kevinzhlj@163.com
Chunxiang Tang, PhD, 13814096738, tangcx@nju.edu.cn
- Recruiting
Longjiang Zhang
Suqian, Jiangsu, 223800
Longjiang Zhang, 13405833167, kevinzhlj@163.com
Feng XU, keyisq@163.com
- Recruiting
Longjiang Zhang
Zhenjiang, Jiangsu, 212001
Longjiang Zhang, 13405833167, kevinzhlj@163.com
Haitao Zhu, zhht25@163.com
About this 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, psychosocial and cognitive assessments, panvascular and body imaging (fundus, carotid artery, chest, abdomen, and heart), electrocardiograms, 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) panvascular and whole-body imaging and electrophysiology-related phenotypes, including fundus OCT, carotid ultrasound, chest and abdominal CT, and cardiac CT, along with electrocardiogram examinations; (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.
- Conditions
- Cardiovascular Diseases, Multi-omics, Living Environments, Pulmonary-cardiovascular Imaging
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once a year until the tenth year
Secondary outcomes (11)
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)
Measured: Once a year until the tenth year
Coronary revascularization
Coronary artery bypass grafting, percutaneous coronary interventions
Measured: 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
Cardiovascular death, heart failure, atrial fibrillation, non-fatal MI, non-fatal stroke, unplanned revascularization, hospitalization for unstable angina
Measured: Once a year until the tenth year
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
Measured: Once every two years at least, until the tenth year
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
Measured: Once every two years at least, until the tenth year
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.
Measured: Once a year until the tenth year
Medication adjustment
Medication adjustment includes the increase or decrease of the drug dose and the new addition or discontinuation of medications after CCTA examination.
Measured: Once a year until the tenth year
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).
Measured: once a year till the tenth year
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)
Measured: Once every five years until the tenth year
Anxiety and cognition
A questionnaire-based follow-up that will mainly focus on anxiety and cognition
Measured: Once every five years until the tenth year
Adverse reactions to iodinated contrast agents
Acute adverse and late adverse reactions to iodinated contrast agents
Measured: Within 1 hour and between 1 hour to 1 week after after contrast agent injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start24 May 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang longjiang,MD, Jinling Hospital, China
- Investigators
- Longjiang Zhang, MD, Principal investigator, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894095
- Sponsor's protocol ID
- 2023NZKY-018-08
- Acronym
- DAILY
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dongzong Cardiovascular Bio-imaging Registry Study
- ClinicalTrials.gov ID
- NCT06894095
- Acronym / sponsor ID
- DAILY / 2023NZKY-018-08
- Conditions
- Cardiovascular Diseases, Multi-omics, Living Environments, Pulmonary-cardiovascular Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2038 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, psychosocial and cognitive assessments, panvascular and body imaging (fundus, carotid artery, chest, abdomen, and heart), electrocardiograms, 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) panvascular and whole-body imaging and electrophysiology-related phenotypes, including fundus OCT, carotid ultrasound, chest and abdominal CT, and cardiac CT, along with electrocardiogram examinations; (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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutively enrolled individuals scheduled for coronary CTA, including those with known or suspected coronary artery disease (CAD) or individuals undergoing screening
Key inclusion criteria (3 listed)
- Aged ≥18 years
- Coronary CT angiography performed
- Informed consent acquired
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Longjiang Zhang, MD principal investigator
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Multi-omics, run by Jinling Hospital, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longjiang Zhang, MD (13405833167, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: Once a year until the tenth year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.