Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTBlood 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.
OTHERDICOM Dataset
Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk.
Sponsors
CHA University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical event | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular death | 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. |
| Nonfatal spontaneous (nonprocedural) myocardial infarction | 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. |
| Nonfatal ischemic stroke | 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. |
| Unplanned hospitalization leading to urgent revascularization | 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. |
| Major bleeding | 3 years after the 1-month assessment (baseline) | Bleeding Academic Research Consortium type 3 or 5 |
| V-Angiographic success | 1 month post-intervention | Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions |
| V-Complete revascularization | 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 |
| AI-Angiographic success | 1 month post-intervention | Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions |
| AI-Complete revascularization | 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 |
| Platelet reactivity | 1 month post-intervention | This will be measured with P2Y12 reaction units through VerifyNow test. |
| Thrombogenicity profiles | 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. |
| Lipid profiles | 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). |
| 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 | — |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeung-Yul Lee, MD
CHA Bundang Medical Center
Outcome results
None listed