- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07393412
Identifying Risk Factors and Predicting Future Health Outcomes for Korean Patients With Heart and Blood Vessel Diseases: A Long-term Follow-up Study
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Seoul, South Korea
- Recruiting
- Samsung Medical Center
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Contact:
- Woo-keun Seo
- Phone Number: +82-2-3410-0799
- Email: mcastenosis@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
A patient who visited Samsung Medical Center due to cardiovascular and cerebrovascular disease.
Exclusion Criteria:
A patient deemed unable to participate in the study based on the judgment of the medical staff.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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)
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Up to 20 years (from the date of enrollment until the end of the follow-up period)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC IRB 2025-12-061
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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