Cardiovascular DiseasesNCT05435898
Assessment and Digital-health Based Intervention on Subclinical Organ Damage and Cardiovascular Risk in Chinese
An observational study of Cardiovascular Diseases and Cardiovascular Morbidity, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events. To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Morbidity, Subclinical Organ Damage
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Sep 2029
- 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
- Adult, Older adult
Study population: All healthy subjects having cardiovascular health check-up and patients with cardiovascular diseases in the cardiovascular research clinic of our hospital are eligible for this study
Who may be able to join
- aged 18 years or older
- willing to participate the study and sign informed consent
- available for long-term follow-up
Who cannot join
- severe heart disease (NYHA IV)
- stage 4 or 5 CKD
- malignant tumors or with life expectancy less than 5 years
- stroke within 3 months
- refuse to participate the study or not available for long-term follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Tenth People's Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200072
Shikai Yu, MD, PhD, +86 18801790211, shikaiyu@yahoo.com
About this study
Official title: Comprehensive Assessment and Digital-health Based Intervention on Early-stage Cardiovascular Organ Damage and Cardiovascular Risk in Chinese: An All-comer Registry Study
To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events.
To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.
Read the detailed description
In this project, we will register outpatients with cardiovascular diseases and healthy subjects for cardiovascular health check-up in the cardiovascular research clinic of our hospital, comprehensively evaluate their cardiovascular risk factors, subclinical organ damage and cardiovascular diseases at baseline. For participants who is willing to go further, a digital-based intervention will be provided for them to improve their knowledge and behaviour on cardiovascular health. For all participants, their status on subclinical organ damage, cardiovascular diseases and events will be followed within five years. The primary outcome is the composite endpoints of cardiovascular adverse events including acute coronary syndrome, myocardial infarction, heart failure, cardiovascular death. The secondary outcomes include individual cardiovascular adverse events, all-cause mortality, subclinical organ damage including cardiac damage (left ventricular hypertrophy and diastolic dysfunction), renal damage (chronic kidney disease, microalbuminuria), and vascular damage (arterial stiffness, plaques, intima-median thickening, retina arteriosclerosis). By doing these, we will be able to build a registry study and to reveal the epidemiology of subclinical organ damage, validate the association between subclinical organ damage and cardiovascular events in Chinese, and explore the significance of digital-based intervention in the prevention from subclinical organ damage and cardiovascular diseases and events.
- Conditions
- Cardiovascular Diseases, Cardiovascular Morbidity, Subclinical Organ Damage, Digital Health
- Keywords
- Coronary Heart Disease, Arterial stiffness, Left ventricular hypertrophy, Left ventricular diastolic dysfunction, Intima-media thickness, Cardiovascular events
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Hypertrophy, Left Ventricular, Ventricular Dysfunction, Left
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of cardiovascular events
rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death
Measured: 5 years
Secondary outcomes (3)
Individual cardiovascular events
rate of subject with individual components of composite endpoint
Measured: 5 years
all cause mortality
rate of death
Measured: 5 years
New on-set subclinical organ damage
Rate of subject with new on-set subclinical organ damage. Subclinical organ damage evaluated contains heart (left ventricular hypertrophy and diastolic dysfunction), kidneys (chronic kidney disease, microalbuminuria), vasculature (arterial stiffness, carotid plaque, intima-media thickness), and eye background (arteriosclerotic retinopathy).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yi Zhang, PhD, MD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435898
- Sponsor's protocol ID
- NSS_2
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang B, Gao Y, Zhao Y, Jia P, Han J, Li H, Zhang Y, Xu Y. Prognostic Value of Angiography-Derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease Undergoing Rotational Atherectomy. Rev Cardiovasc Med. 2023 Apr 27;24(5):131. doi: 10.31083/j.rcm2405131. eCollection 2023 May.
PubMed 39076748Hou J, Li M, Han J, Yu S, Jia X, Sun F, Zhang Y. Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk-protocol of a prospective study. BMJ Open. 2023 Dec 30;13(12):e073423. doi: 10.1136/bmjopen-2023-073423.
PubMed 38159946Wang B, Gao Y, Zhao Y, Xu C, Zhao S, Li H, Zhang Y, Xu Y. The spectrum of angiography-derived IMR according to morphological and physiological coronary stenosis in patients with suspected myocardial ischemia. Clin Cardiol. 2023 May;46(5):502-511. doi: 10.1002/clc.23999. Epub 2023 Mar 1.
PubMed 36855931
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment and Digital-health Based Intervention on Early-stage Cardiovascular Organ Damage and Cardiovascular Risk in Chinese: An All-comer Registry Study
- ClinicalTrials.gov ID
- NCT05435898
- Acronym / sponsor ID
- NSS_2
- Conditions
- Cardiovascular Diseases, Cardiovascular Morbidity, Subclinical Organ Damage, Digital Health
- Keywords
- Coronary Heart Disease, Arterial stiffness, Left ventricular hypertrophy, Left ventricular diastolic dysfunction, Intima-media thickness, Cardiovascular events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 28 Jun 2022 (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.
To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events.
To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.
Detailed description
In this project, we will register outpatients with cardiovascular diseases and healthy subjects for cardiovascular health check-up in the cardiovascular research clinic of our hospital, comprehensively evaluate their cardiovascular risk factors, subclinical organ damage and cardiovascular diseases at baseline. For participants who is willing to go further, a digital-based intervention will be provided for them to improve their knowledge and behaviour on cardiovascular health. For all participants, their status on subclinical organ damage, cardiovascular diseases and events will be followed within five years. The primary outcome is the composite endpoints of cardiovascular adverse events including acute coronary syndrome, myocardial infarction, heart failure, cardiovascular death. The secondary outcomes include individual cardiovascular adverse events, all-cause mortality, subclinical organ damage including cardiac damage (left ventricular hypertrophy and diastolic dysfunction), renal damage (chronic kidney disease, microalbuminuria), and vascular damage (arterial stiffness, plaques, intima-median thickening, retina arteriosclerosis). By doing these, we will be able to build a registry study and to reveal the epidemiology of subclinical organ damage, validate the association between subclinical organ damage and cardiovascular events in Chinese, and explore the significance of digital-based intervention in the prevention from subclinical organ damage and cardiovascular diseases and events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All healthy subjects having cardiovascular health check-up and patients with cardiovascular diseases in the cardiovascular research clinic of our hospital are eligible for this study
Key inclusion criteria (3 listed)
- aged 18 years or older
- willing to participate the study and sign informed consent
- available for long-term follow-up
Key exclusion criteria (5 listed)
- severe heart disease (NYHA IV)
- stage 4 or 5 CKD
- malignant tumors or with life expectancy less than 5 years
- stroke within 3 months
- refuse to participate the study or not available for long-term follow up
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
composite endpoint of cardiovascular events
Time frame: 5 years
rate of subject with myocardial infarction, stroke, heart failure, cardiovascular death
3 secondary outcomes
Individual cardiovascular events
Time frame: 5 years
all cause mortality
Time frame: 5 years
New on-set subclinical organ damage
Time frame: 5 years
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 28 Jun 2022.
- Derived from this study: PubMed 39076748Wang B, Gao Y, Zhao Y, Jia P, Han J, Li H, Zhang Y, Xu Y. Prognostic Value of Angiography-Derived Index of Microcirculatory Resistance in Patients with Coronary Artery Disease Undergoing Rotational Atherectomy. Rev Cardiovasc Med. 2023 Apr 27;24(5):131. doi: 10.31083/j.rcm2405131. eCollection 2023 May.
- Derived from this study: PubMed 38159946Hou J, Li M, Han J, Yu S, Jia X, Sun F, Zhang Y. Northern Shanghai Study II: systematic assessment and management of early organ damage and its role in preventing and reducing cardiovascular risk-protocol of a prospective study. BMJ Open. 2023 Dec 30;13(12):e073423. doi: 10.1136/bmjopen-2023-073423.
- Derived from this study: PubMed 36855931Wang B, Gao Y, Zhao Y, Xu C, Zhao S, Li H, Zhang Y, Xu Y. The spectrum of angiography-derived IMR according to morphological and physiological coronary stenosis in patients with suspected myocardial ischemia. Clin Cardiol. 2023 May;46(5):502-511. doi: 10.1002/clc.23999. Epub 2023 Mar 1.
- Individual participant dataSharing planned: Undecided
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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.
Shanghai Tenth People's Hospital, Tongji University School of Medicine
Shanghai, China
Yi Zhang, PhD, MD principal investigator
Shanghai 10th People's Hospital
1 site 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 Cardiovascular Morbidity, run by Shanghai 10th People's Hospital at 1 site 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: opening soon, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of cardiovascular events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435898, which also lists 3 linked publications.
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 28 Jun 2022.