Cardiovascular DiseasesNCT06992284
A Prognostic Study for Patients With Cardiovascular Disease in Niigata
An observational study of Cardiovascular Diseases and Heart Failure, run by Niigata University Medical & Dental Hospital at 1 site in Japan.
Trial summary
The goal of this observational study is to investigate the prognosis of cardiovascular disease in Niigata Prefecture. Specifically, it aims to clarify the current status of medical treatment for cardiovascular disease patients in regional cities in Japan, where the population is aging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Failure
- How many people
- 8,500 participants
- Where
- 1 siteJapan
- Study dates
- 12 May 2025to May 2050
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants are individuals aged 18 or older who have been hospitalized in the cardiology department of a participating medical institution and are covered by Japan's National Health Insurance or the Late-stage Elderly Medical Care System
Who may be able to join
- Individuals aged 18 or older at the time of enrollment (regardless of gender).
- Individuals who have been hospitalized in the cardiology department of a participating medical institution.
- Individuals covered by Japan's National Health Insurance (NHI) or the Late-stage Elderly Medical Care System, which provide health coverage for self-employed individuals, retirees, and the elderly.
Who cannot join
- Individuals who are unable to obtain consent from themselves or their legally authorized representatives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prognostic Study Using Health Insurance Claim for Patients With Cardiovascular Disease in Niigata
The goal of this observational study is to investigate the prognosis of cardiovascular disease in Niigata Prefecture.
Specifically, it aims to clarify the current status of medical treatment for cardiovascular disease patients in regional cities in Japan, where the population is aging.
With patient consent, the study will track long-term medical treatment progress using health insurance claim data recorded in Japan's unique social security system.
- Conditions
- Cardiovascular Diseases, Heart Failure
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of deterioration in care dependency levels as defined by Japan's Long-Term Care Insurance system
through study completion, an average of 1 year
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start12 May 2025
- Primary completion31 Dec 2047 (estimated)
- Study completionMay 2050 (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
- 8,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niigata University Medical & Dental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992284
- Sponsor's protocol ID
- 2024-0250
- Status last verified
- May 2025
- First submitted
- 5 Mar 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prognostic Study Using Health Insurance Claim for Patients With Cardiovascular Disease in Niigata
- ClinicalTrials.gov ID
- NCT06992284
- Acronym / sponsor ID
- 2024-0250
- Conditions
- Cardiovascular Diseases, Heart Failure
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,500 participants (estimated)
- Lead sponsor
- Niigata University Medical & Dental HospitalUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Dec 2047 (estimated)
- Study completion
- May 2050 (estimated)
- First posted
- 28 May 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 goal of this observational study is to investigate the prognosis of cardiovascular disease in Niigata Prefecture.
Specifically, it aims to clarify the current status of medical treatment for cardiovascular disease patients in regional cities in Japan, where the population is aging.
With patient consent, the study will track long-term medical treatment progress using health insurance claim data recorded in Japan's unique social security system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants are individuals aged 18 or older who have been hospitalized in the cardiology department of a participating medical institution and are covered by Japan's National Health Insurance or the Late-stage Elderly Medical Care System
Key inclusion criteria (3 listed)
- Individuals aged 18 or older at the time of enrollment (regardless of gender).
- Individuals who have been hospitalized in the cardiology department of a participating medical institution.
- Individuals covered by Japan's National Health Insurance (NHI) or the Late-stage Elderly Medical Care System, which provide health coverage for self-employed individuals, retirees, and the elderly.
Key exclusion criteria (1 listed)
- Individuals who are unable to obtain consent from themselves or their legally authorized representatives.
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
The rate of deterioration in care dependency levels as defined by Japan's Long-Term Care Insurance system
Time frame: through study completion, an average of 1 year
through study completion, an average of 1 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 28 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure, run by Niigata University Medical & Dental Hospital at 1 site in Japan.
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 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: enrolling by invitation, as of the sponsor's last update on 28 May 2025. 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 Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of deterioration in care dependency levels as defined by Japan's Long-Term Care Insurance system (time frame: through study completion, an average of 1 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 28 May 2025.