Cardiovascular DiseasesNCT05431400
Reduction of Risk for Cardiovascular Diseases
An observational study of Cardiovascular Diseases, run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
To establish and evaluate a new prediction model for assessing cardiovascular disease risk in community-dwelling adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 20,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Community-dwelling adults in Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project. To participate in the Chinese National Basic Public Health Service project, one must meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension.
Who may be able to join
- Meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension;
Who cannot join
- Refuse to provide informed consent;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Fourth People's Hospital of Foshan
Foshan, Guangdong, 528041
Guifang Hu, MD, +86-020-61648653, guif_hu@sina.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jiancheng Xiu, MD, 86-020-61648165 ext. 41049, xiujch@163.com
About this study
Official title: Reducing the Risk of Cardiovascular Diseases in Community-dwelling Adults: an Ambispective Cohort Study
To establish and evaluate a new prediction model for assessing cardiovascular disease risk in community-dwelling adults.
Read the detailed description
This is an ambispective, observational cohort study. In the retrospective part, we will enroll residents from Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project between January 2015 and December 2019. The demographic characteristics, anthropometric measurements, laboratory assays, medical history, living habits, and medications will be collected through personal electronic health records obtained from the regional chronic disease management platform. In the prospective part, residents who participated in the annual health checks provided by the Chinese National Basic Public Health Service project after January 2020 will be enrolled. In addition to the data collected in the retrospective part, blood, urine and fecal samples and lifestyle questionnaires will be collected for further analysis. All participants will be followed-up till December 2025. A new prediction model for assessing cardiovascular disease risk will be established and evaluated.
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Prediction model, Community
- 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
Major adverse cardiovascular events include all-cause mortality, acute myocardial infarction, coronary heart disease, heart failure and stroke.
Measured: 5 years
Secondary outcomes (6)
Atherosclerotic cardiovascular events
Atherosclerotic cardiovascular events include acute myocardial infarction, coronary heart disease, heart failure and fatal and non-fatal stroke.
Measured: 5 years
All-cause mortality
Defined as any death after enrollment.
Measured: 5 years
Cognitive dysfunction
Defined as Montreal Cognitive Assessment (MoCA) Score < 26 points.
Measured: 5 years
Renal functional deterioration
Evaluated through change in estimated glomerular filtration rate.
Measured: 5 years
Renal replacement therapy and/or death due to acute renal failure
Measured: 5 years
Incident atrial fibrillation
Atrial fibrillation is diagnosed according to the 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation.
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 posted24 Jun 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiancheng Xiu, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431400
- Sponsor's protocol ID
- NFEC-2021-083
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Risk of Cardiovascular Diseases in Community-dwelling Adults: an Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT05431400
- Acronym / sponsor ID
- NFEC-2021-083
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular Diseases, Prediction model, Community
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 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 establish and evaluate a new prediction model for assessing cardiovascular disease risk in community-dwelling adults.
Detailed description
This is an ambispective, observational cohort study. In the retrospective part, we will enroll residents from Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project between January 2015 and December 2019. The demographic characteristics, anthropometric measurements, laboratory assays, medical history, living habits, and medications will be collected through personal electronic health records obtained from the regional chronic disease management platform. In the prospective part, residents who participated in the annual health checks provided by the Chinese National Basic Public Health Service project after January 2020 will be enrolled. In addition to the data collected in the retrospective part, blood, urine and fecal samples and lifestyle questionnaires will be collected for further analysis. All participants will be followed-up till December 2025. A new prediction model for assessing cardiovascular disease risk will be established and evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling adults in Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project. To participate in the Chinese National Basic Public Health Service project, one must meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension.
Key inclusion criteria (1 listed)
- Meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension;
Key exclusion criteria (1 listed)
- Refuse to provide informed consent;
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: 5 years
Major adverse cardiovascular events include all-cause mortality, acute myocardial infarction, coronary heart disease, heart failure and stroke.
6 secondary outcomes
Atherosclerotic cardiovascular events
Time frame: 5 years
All-cause mortality
Time frame: 5 years
Cognitive dysfunction
Time frame: 5 years
Renal functional deterioration
Time frame: 5 years
Renal replacement therapy and/or death due to acute renal failure
Time frame: 5 years
Incident atrial fibrillation
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- 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. This study is not recruiting at the moment.
Jiancheng Xiu, MD principal investigator
Nanfang Hospital, Southern Medical University
2 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, run by Nanfang Hospital, Southern Medical University at 2 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 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 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiancheng Xiu, MD (+86-020-61648319, xiujch@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: 5 years). 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 24 Jun 2022.