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NCT Number: NCT07393412

Identifying Risk Factors and Predicting Future Health Outcomes for Korean Patients With Heart and Blood Vessel Diseases: A Long-term Follow-up Study

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Medical Therapy

Drug

Routine pharmacological treatments including antiplatelets, antihypertensives

Revascularization Procedures

Procedure

Surgical or interventional procedures such as PCI (Percutaneous Coronary Intervention) or stent thrombectomy for stroke.

Lifestyle Modification

Behavioral

Habitual factors including smoking cessation, physical activity, and dietary habits monitored during the follow-up.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

PRIME (Precision Registry for Integrated Cardio-cerebrovascular Medicine & Evidence)

Important dates

Study start
2026
Primary completion
2026
Study completion
2040
First posted
Feb 6, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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