Cardiovascular Diseases (CVD)NCT07393412
Identifying Risk Factors and Predicting Future Health Outcomes for Korean Patients With Heart and Blood Vessel Diseases: A Long-term Follow-up Study
An observational study of Cardiovascular Diseases (CVD) and Cerebro Vascular Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to establish a comprehensive, long-term clinical registry infrastructure for heart and brain vascular diseases (cardiovascular diseases and stroke) at Samsung Medical Center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases (CVD), Cerebro Vascular Disease
- What is being tested?
- Standard Medical Therapy, Revascularization Procedures and Lifestyle Modification
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 800,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Feb 2026to 31 Dec 2040
- How long will I take part?
- 20 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of patients diagnosed with or treated for heart and brain vascular diseases (cardiovascular diseases and stroke) at Samsung Medical Center, a tertiary academic hospital in Seoul, Korea. This cohort includes: Retrospective Group: Patients with clinical records within the hospital's historical database to analyze past clinical courses and long-term outcomes. Prospective Group: Patients newly visiting or currently under follow-up care at the heart, stroke, and vascular centers who consent to long-term monitoring. The population covers a wide clinical spectrum, from acute emergency cases (e.g., myocardial infarction, ischemic stroke) to chronic management.
Who may be able to join
- A patient who visited Samsung Medical Center due to cardiovascular and cerebrovascular disease.
Who cannot join
- A patient deemed unable to participate in the study based on the judgment of the medical staff.
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
Samsung Medical Center
Seoul
Woo-keun Seo, +82-2-3410-0799, mcastenosis@gmail.com
About this study
Official title: PRIME (Precision Registry for Integrated Cardio-cerebrovascular Medicine & Evidence)
This study aims to establish a comprehensive, long-term clinical registry infrastructure for heart and brain vascular diseases (cardiovascular diseases and stroke) at Samsung Medical Center. In South Korea, these diseases are a leading cause of death, with a rapidly increasing burden due to an aging population and changing lifestyles. Despite this, there is a lack of large-scale, systematic data specifically focused on the long-term clinical course and unique characteristics of Korean patients.
The central hypothesis of this study is that the establishment of a standardized registry infrastructure-integrating both retrospective (historical) and prospective (future) data collection-will provide a more accurate and comprehensive understanding of the natural history and risk factors of heart and brain vascular diseases in the Korean population than currently available fragmented data. By combining existing medical records with ongoing patient follow-up, this infrastructure will serve as a critical scientific platform for developing personalized prevention and precision medicine strategies.
Read more
By building this organized data collection system, the study will:
Construct a robust infrastructure to collect uniform, high-quality clinical data, encompassing both past medical history (retrospective) and future clinical progress (prospective) from a large population of Korean patients.
Monitor long-term health outcomes and the progression of diseases by tracking patients over many years.
Analyze the interaction between various risk factors and patient outcomes to identify population-specific patterns.
Create a scalable platform that can integrate advanced technologies, such as multi-omics and digital health tools, for future research.
Ultimately, this integrated registry infrastructure is expected to provide the essential scientific evidence needed to optimize clinical guidelines and improve the long-term quality of life for patients with heart and brain vascular diseases in Korea.
- Being tested
- Standard Medical Therapy, Revascularization Procedures, Lifestyle Modification
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical TherapyDrug
Routine pharmacological treatments including antiplatelets, antihypertensives
Revascularization ProceduresProcedure or surgery
Surgical or interventional procedures such as PCI (Percutaneous Coronary Intervention) or stent thrombectomy for stroke.
Lifestyle ModificationBehavioural
Habitual factors including smoking cessation, physical activity, and dietary habits monitored during the follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Cardio-Cerebrovascular Events (MACCE)
Measured: Up to 20 years (from the date of enrollment until the end of the follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start2 Feb 2026
- Primary completion27 Nov 2026 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 800,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393412
- Sponsor's protocol ID
- SMC IRB 2025-12-061
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIME (Precision Registry for Integrated Cardio-cerebrovascular Medicine & Evidence)
- ClinicalTrials.gov ID
- NCT07393412
- Acronym / sponsor ID
- SMC IRB 2025-12-061
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 6 Feb 2026 (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.
This study aims to establish a comprehensive, long-term clinical registry infrastructure for heart and brain vascular diseases (cardiovascular diseases and stroke) at Samsung Medical Center. In South Korea, these diseases are a leading cause of death, with a rapidly increasing burden due to an aging population and changing lifestyles. Despite this, there is a lack of large-scale, systematic data specifically focused on the long-term clinical course and unique characteristics of Korean patients.
The central hypothesis of this study is that the establishment of a standardized registry infrastructure-integrating both retrospective (historical) and prospective (future) data collection-will provide a more accurate and comprehensive understanding of the natural history and risk factors of heart and brain vascular diseases in the Korean population than currently available fragmented data. By combining existing medical records with ongoing patient follow-up, this infrastructure will serve as a critical scientific platform for developing personalized prevention and precision medicine strategies.
By building this organized data collection system, the study will:
Construct a robust infrastructure to collect uniform, high-quality clinical data, encompassing both past medical history (retrospective) and future clinical progress (prospective) from a large population of Korean patients.
Monitor long-term health outcomes and the progression of diseases by tracking patients over many years.
Analyze the interaction between various risk factors and patient outcomes to identify population-specific patterns.
Create a scalable platform that can integrate advanced technologies, such as multi-omics and digital health tools, for future research.
Ultimately, this integrated registry infrastructure is expected to provide the essential scientific evidence needed to optimize clinical guidelines and improve the long-term quality of life for patients with heart and brain vascular diseases in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients diagnosed with or treated for heart and brain vascular diseases (cardiovascular diseases and stroke) at Samsung Medical Center, a tertiary academic hospital in Seoul, Korea. This cohort includes: Retrospective Group: Patients with clinical records within the hospital's historical database to analyze past clinical courses and long-term outcomes. Prospective Group: Patients newly visiting or currently under follow-up care at the heart, stroke, and vascular centers who consent to long-term monitoring. The population covers a wide clinical spectrum, from acute emergency cases (e.g., myocardial infarction, ischemic stroke) to chronic management.
Key inclusion criteria (1 listed)
- A patient who visited Samsung Medical Center due to cardiovascular and cerebrovascular disease.
Key exclusion criteria (1 listed)
- A patient deemed unable to participate in the study based on the judgment of the medical staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Medical TherapyRoutine pharmacological treatments including antiplatelets, antihypertensives | Drug | – |
| Revascularization ProceduresSurgical or interventional procedures such as PCI (Percutaneous Coronary Intervention) or stent thrombectomy for stroke. | Procedure or surgery | – |
| Lifestyle ModificationHabitual factors including smoking cessation, physical activity, and dietary habits monitored during the follow-up. | Behavioural | – |
Primary outcome
Incidence of Major Adverse Cardio-Cerebrovascular Events (MACCE)
Time frame: Up to 20 years (from the date of enrollment until the end of the follow-up period)
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 Apr 2026.
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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.
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 (CVD) and Cerebro Vascular Disease, run by Samsung Medical Center 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 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. 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?
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?
Incidence of Major Adverse Cardio-Cerebrovascular Events (MACCE) (time frame: Up to 20 years (from the date of enrollment until the end of the follow-up period)). 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 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.