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NCT Number: NCT06619353

RCVR (Residual CardioVascular Risk) 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. Major bleeding

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

    Bleeding Academic Research Consortium type 3 or 5

  6. 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

  7. 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

  8. 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

  9. 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

  10. Platelet reactivity

    Time frame: 1 month post-intervention

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

  11. 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.

  12. 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).

  13. Hemoglobin A1C

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

  14. High-sensitivity C-reactive protein

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

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

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

Acronym: RCVR

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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