RCVR (Residual CardioVascular Risk) Prospective Study (RCVR)

Residual CardioVascular Risk (RCVR) After Percutaneous Coronary Intervention: A Prospective Study

The goal of this observational study is to evaluate whether residual cardiovascular risk assessed at 1 month after percutaneous coronary intervention (PCI) is associated with long-term clinical outcomes in adult patients with coronary artery disease who are free from major adverse clinical events at 1 month after PCI. The main questions it aims to answer are:

• Does residual cardiovascular risk at 1 month after PCI predict long-term net adverse clinical events?
• Which components of residual cardiovascular risk are associated with subsequent adverse clinical outcomes?

Participants will:

• Undergo comprehensive laboratory testing at 1 month after PCI and annually thereafter.
• Undergo artificial intelligence-based quantitative coronary angiographic analysis using DICOM datasets after PCI.
• Be followed annually for up to 3 years after the 1-month assessment to evaluate clinical outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Blood Sample; Other: DICOM Dataset

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13496
      • CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PCI

Description

Inclusion Criteria:

• Patients who have undergone percutaneous coronary intervention.
• Patients who are free from death, myocardial infarction, stroke, unplanned revascularization, or major bleeding within 1 month after the index PCI.
• Patients who are able to undergo artificial intelligence-based quantitative coronary angiography using DICOM datasets.
• Patients who have provided written informed consent at the 1-month post-PCI visit.

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.
• Occurrence of death, myocardial infarction, stroke, unplanned revascularization, or major bleeding within 1 month after the index PCI.
• Inability or unwillingness to comply with scheduled follow-up assessments.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Residual CardioVascular Risk; Residual cardiovascular risk is assessed in patients undergoing PCI.	Diagnostic test: 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.; Other: DICOM Dataset; Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net adverse clinical event	The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding.	3 years after the 1-month assessment (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	The composite of cardiac and vascular death. Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases will be classified as vascular death.	3 years after the 1-month assessment (baseline)
Nonfatal spontaneous (nonprocedural) myocardial infarction	Myocardial infarction is defined as symptoms, electrocardiographic changes, or abnormal imaging findings, combined with a creatine kinase MB fraction above the upper normal limits or a troponin T or troponin I level greater than the 99th percentile of the upper normal limit. Myocardial infarction that are not associated with a revascularization procedure will be classified as nonfatal spontaneous myocardial infarction.	3 years after the 1-month assessment (baseline)
Nonfatal ischemic stroke	Cerebrovascular event resulting in a neurologic deficit within 24 hours or the presence of acute infarction as demonstrated by imaging studies will be classified as nonfatal ischemic stroke.	3 years after the 1-month assessment (baseline)
Unplanned hospitalization leading to urgent revascularization	This event will be present only if the participant is hospitalized unexpectedly because of persisting or increasing complaints of chest pain (with or without ST-T changes, with or without elevated biomarkers) and a revascularization is performed within the same hospitalization. It should be clearly distinguished from the revascularization procedure which is performed on non-urgent basis.	3 years after the 1-month assessment (baseline)
Major bleeding	Bleeding Academic Research Consortium type 3 or 5	3 years after the 1-month assessment (baseline)
V-Angiographic success	Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions	1 month post-intervention
V-Complete revascularization	Participant without angiographically significant stenosis (visually estimated diameter stenosis severity of ≥70% for non-left main disease and ≥50% for left main disease) after PCI in entire coronary arteries	1 month post-intervention
AI-Angiographic success	Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions	1 month post-intervention
AI-Complete revascularization	Participant without angiographically significant stenosis (artificial intelligence-measured diameter stenosis severity of ≥70% for non-left main disease and ≥50% for left main disease) after PCI in entire coronary arteries	1 month post-intervention
Platelet reactivity	This will be measured with P2Y12 reaction units through VerifyNow test.	1 month post-intervention
Thrombogenicity profiles	This will include R, K, Angle, A10, MA, and Ly30 through thromboelastography.	1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
Lipid profiles	This will include total cholesterol, high-density lipoprotein, low-density lipoprotein, and lipoprotein (a).	1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
Hemoglobin A1C		1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
High-sensitivity C-reactive protein		1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline

Collaborators and Investigators

• Sponsor: CHA University
• Investigators: Principal Investigator: Seung-Yul Lee, MD, CHA Bundang Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: CHAMC IRB 2024-01-054-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No