RCVR (Residual CardioVascular Risk) Prospective Multicenter Study

NCT ID: NCT06619353

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-17

Study Completion Date

2029-12-31

Brief Summary

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The observational study aims to evaluate the long-term effects of residual cardiovascular risk on clinical outcomes following percutaneous coronary intervention (PCI). This risk includes thrombotic, metabolic, inflammatory, and procedural factors, which are assessed 1 month after the intervention. The primary question the study seeks to answer is:

What residual cardiovascular risk affects long-term clinical outcomes in patients undergoing PCI?

Participants will undergo artificial intelligence-based quantitative coronary analysis after PCI and will have comprehensive laboratory tests conducted at 1 month to evaluate residual cardiovascular risk, and then annually for 3 years post-intervention to assess changes in this risk.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Residual CardioVascular Risk

Residual cardiovascular risk is assessed in patients undergoing PCI.

Blood Sample

Intervention Type DIAGNOSTIC_TEST

Patients' blood samples are tested at 1 month, and then annually for 3 years post-intervention to assess residual thrombotic, metabolic, and inflammatory risk.

DICOM Dataset

Intervention Type OTHER

Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.

Interventions

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Blood Sample

Patients' blood samples are tested at 1 month, and then annually for 3 years post-intervention to assess residual thrombotic, metabolic, and inflammatory risk.

Intervention Type DIAGNOSTIC_TEST

DICOM Dataset

Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have undergone percutaneous coronary intervention.
* Patients who have provided written informed consent.

Exclusion Criteria

* Under 19 years of age.
* Pregnant, breastfeeding, or women of childbearing age.
* Currently has a malignancy or has a history of malignancy within the past 5 years.
* Life expectancy of less than 5 years.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHA University

OTHER

Sponsor Role lead

Responsible Party

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Seung-Yul Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung-Yul Lee, MD

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

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CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hwa-In Kim

Role: CONTACT

82-31-780-5858

Seung-Yul Lee

Role: CONTACT

82-31-780-5858

Facility Contacts

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Seung-Yul Lee, MD

Role: primary

82-31-780-5858

References

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Dhindsa DS, Sandesara PB, Shapiro MD, Wong ND. The Evolving Understanding and Approach to Residual Cardiovascular Risk Management. Front Cardiovasc Med. 2020 May 13;7:88. doi: 10.3389/fcvm.2020.00088. eCollection 2020.

Reference Type BACKGROUND
PMID: 32478100 (View on PubMed)

Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

Reference Type BACKGROUND
PMID: 17470709 (View on PubMed)

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

Reference Type BACKGROUND
PMID: 21670242 (View on PubMed)

Other Identifiers

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CHAMC IRB 2024-01-054-004

Identifier Type: -

Identifier Source: org_study_id

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