RCVR (Residual CardioVascular Risk) Prospective Multicenter Study
NCT ID: NCT06619353
Last Updated: 2024-10-01
Study Results
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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RECRUITING
1000 participants
OBSERVATIONAL
2024-06-17
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Residual CardioVascular Risk
Residual cardiovascular risk is assessed in patients undergoing PCI.
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.
DICOM Dataset
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.
DICOM Dataset
Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.
Eligibility Criteria
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Inclusion Criteria
* Patients who have provided written informed consent.
Exclusion Criteria
* 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.
20 Years
90 Years
ALL
No
Sponsors
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CHA University
OTHER
Responsible Party
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Seung-Yul Lee
Associate Professor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
Other Identifiers
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CHAMC IRB 2024-01-054-004
Identifier Type: -
Identifier Source: org_study_id
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