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Coronary Artery DiseaseRCVRNCT06619353

RCVR (Residual CardioVascular Risk) Prospective Study

An observational study of Coronary Artery Disease, run by CHA University at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Blood Sample and DICOM Dataset
How many people
500 participants
Where
1 siteSouth Korea
Study dates
17 Jun 2024to Feb 2029
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing PCI

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

Other trials in South Korea

About this study

Official title: 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?
Read more

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.
Being tested
Blood Sample, DICOM Dataset
Keywords
Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood SampleDiagnostic 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 DatasetOther

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

Study groups in NCT06619353
Study groupRoleWhat they receive
Residual CardioVascular RiskResidual cardiovascular risk is assessed in patients undergoing PCI.
Receives: Diagnostic Test: Blood Sample; Other: DICOM Dataset

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years after the 1-month assessment (baseline)

Secondary outcomes (14)

  1. 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.

    Measured: 3 years after the 1-month assessment (baseline)

  2. 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.

    Measured: 3 years after the 1-month assessment (baseline)

  3. 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.

    Measured: 3 years after the 1-month assessment (baseline)

  4. 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.

    Measured: 3 years after the 1-month assessment (baseline)

  5. Major bleeding

    Bleeding Academic Research Consortium type 3 or 5

    Measured: 3 years after the 1-month assessment (baseline)

  6. V-Angiographic success

    Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions

    Measured: 1 month post-intervention

  7. 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

    Measured: 1 month post-intervention

  8. AI-Angiographic success

    Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions

    Measured: 1 month post-intervention

  9. 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

    Measured: 1 month post-intervention

  10. Platelet reactivity

    This will be measured with P2Y12 reaction units through VerifyNow test.

    Measured: 1 month post-intervention

  11. Thrombogenicity profiles

    This will include R, K, Angle, A10, MA, and Ly30 through thromboelastography.

    Measured: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline

  12. Lipid profiles

    This will include total cholesterol, high-density lipoprotein, low-density lipoprotein, and lipoprotein (a).

    Measured: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline

  13. Hemoglobin A1C

    Measured: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline

  14. High-sensitivity C-reactive protein

    Measured: 1 month post-intervention (baseline), 1 year, 2 year, and 3 years after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start17 Jun 2024
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619353
Sponsor's protocol ID
CHAMC IRB 2024-01-054-004
Acronym
RCVR
Status last verified
Feb 2026
First submitted
23 Sep 2024
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32478100

  • 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.

    PubMed 17470709

  • 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.

    PubMed 21670242

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by CHA University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net adverse clinical event (time frame: 3 years after the 1-month assessment (baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619353, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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