RCVR (Residual CardioVascular Risk) Prospective Study (RCVR)

February 15, 2026 updated by: Seung-Yul Lee, CHA University

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Net adverse clinical event
Time Frame: 3 years after the 1-month assessment (baseline)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: 3 years after the 1-month assessment (baseline)
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
Time Frame: 3 years after the 1-month assessment (baseline)
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
Time Frame: 3 years after the 1-month assessment (baseline)
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
Time Frame: 3 years after the 1-month assessment (baseline)
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
Time Frame: 3 years after the 1-month assessment (baseline)
Bleeding Academic Research Consortium type 3 or 5
3 years after the 1-month assessment (baseline)
V-Angiographic success
Time Frame: 1 month post-intervention
Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions
1 month post-intervention
V-Complete revascularization
Time Frame: 1 month post-intervention
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
Time Frame: 1 month post-intervention
Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions
1 month post-intervention
AI-Complete revascularization
Time Frame: 1 month post-intervention
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
Time Frame: 1 month post-intervention
This will be measured with P2Y12 reaction units through VerifyNow test.
1 month post-intervention
Thrombogenicity profiles
Time Frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
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
Time Frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
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
Time Frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
High-sensitivity C-reactive protein
Time Frame: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline
1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHA University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Yul Lee, MD, CHA Bundang Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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