Cardiovascular DiseasesNCT05389956
Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study
An observational study of Cardiovascular Diseases and Malignancy, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Malignancy, Risk Factor
- How many people
- 510,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2023to Aug 2052
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health screening participants aged 19 years and older from community and workplace
Who may be able to join
- Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)
- Subjects have to agree to participate by signing a consent
Who cannot join
- Subjects who cannot or reject to sign the consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Sangwoo Park, MD, warya7@naver.com
Sangwoo Park, MD
About this study
Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.
Read the detailed description
This is a single center, observational, prospective cohort study. The primary outcomes include the incidence of MACE (major adverse cardiovascular events) and the incidence of any malignancy. We plan to collect the baseline information at enrollment and the occurrence of clinical endpoint events will be followed for at least 10 years. The study will enroll 510,000 subjects aged ≥19 years who underwent a general health screening in Korea.
- Conditions
- Cardiovascular Diseases, Malignancy, Risk Factor
- Keywords
- Cardiovascular disease, Malignancy, Risk factor
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ulsan University Hospital-Health Screening Cohort (UUH-HEALS) | Ulsan University Hospital-Health Screening Cohort is a prospective cohort of participants who participated in general health screening programs at the Health Promotion Center of Ulsan University Hospital (Ulsan, South Korea). This cohort includes health screening participants aged 19 years and older from community and workplace. The purpose of this cohort is to offer relevant and useful data on health risk factors in the field of non-communicable diseases such as cardiovascular disease and malignancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular event (MACE)
A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke
Measured: 10 year
Incidence of malignancy
The occurrence of any malignancy of interest
Measured: 10 year
Secondary outcomes (5)
All-cause death
Measured: 10 year
Cardiovascular death
Measured: 10 year
Myocardial infarction
Measured: 10 year
Stroke
Measured: 10 year
Cancer related mortality
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jan 2023
- Primary completionAug 2042 (estimated)
- Study completionAug 2052 (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
- 510,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangwoo Park, Ulsan University Hospital
- Investigators
- Sangwoo Park, MD, Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389956
- Sponsor's protocol ID
- 2021-12-014-003
- Status last verified
- Mar 2024
- First submitted
- 21 May 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05389956
- Acronym / sponsor ID
- 2021-12-014-003
- Conditions
- Cardiovascular Diseases, Malignancy, Risk Factor
- Keywords
- Cardiovascular disease, Malignancy, Risk factor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 510,000 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Aug 2042 (estimated)
- Study completion
- Aug 2052 (estimated)
- First posted
- 25 May 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.
Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.
Detailed description
This is a single center, observational, prospective cohort study. The primary outcomes include the incidence of MACE (major adverse cardiovascular events) and the incidence of any malignancy. We plan to collect the baseline information at enrollment and the occurrence of clinical endpoint events will be followed for at least 10 years. The study will enroll 510,000 subjects aged ≥19 years who underwent a general health screening in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulsan University Hospital-Health Screening Cohort (UUH-HEALS) | – | –Ulsan University Hospital-Health Screening Cohort is a prospective cohort of participants who participated in general health screening programs at the Health Promotion Center of Ulsan University Hospital (Ulsan, South Korea). This cohort includes health screening participants aged 19 years and older from community and workplace. The purpose of this cohort is to offer relevant and useful data on health risk factors in the field of non-communicable diseases such as cardiovascular disease and malignancy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health screening participants aged 19 years and older from community and workplace
Key inclusion criteria (2 listed)
- Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)
- Subjects have to agree to participate by signing a consent
Key exclusion criteria (1 listed)
- Subjects who cannot or reject to sign the consent form.
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 event (MACE)
Time frame: 10 year
A major adverse cardiovascular event (MACE) of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke
Incidence of malignancy
Time frame: 10 year
The occurrence of any malignancy of interest
5 secondary outcomes
All-cause death
Time frame: 10 year
Cardiovascular death
Time frame: 10 year
Myocardial infarction
Time frame: 10 year
Stroke
Time frame: 10 year
Cancer related mortality
Time frame: 10 year
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 19 Mar 2024.
- 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.
Sangwoo Park, MD principal investigator
Ulsan University 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 Malignancy, run by Ulsan University Hospital at 1 site in South Korea.
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 2 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: looking for participants now, as of the sponsor's last update on 19 Mar 2024. 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 South Korea. 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 Sangwoo Park, MD (82-52-250-8669, warya7@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular event (MACE) (time frame: 10 year). The study lists 2 primary outcomes in all. 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 19 Mar 2024.