RCVR (Residual CardioVascular Risk) Prospective Multicenter Study
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: Blood SampleOther: DICOM Dataset
- Registration Number
- NCT06619353
- Lead Sponsor
- CHA University
- Brief Summary
The observational study aims to evaluate the long-term effects of residual cardiovascular risk on clinical outcomes following percutaneous coronary intervention (PCI). This risk includes thrombotic, metabolic, inflammatory, and procedural factors, which are assessed 1 month after the intervention. The primary question the study seeks to answer is:
What residual cardiovascular risk affects long-term clinical outcomes in patients undergoing PCI?
Participants will undergo artificial intelligence-based quantitative coronary analysis after PCI and will have comprehensive laboratory tests conducted at 1 month to evaluate residual cardiovascular risk, and then annually for 3 years post-intervention to assess changes in this risk.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Patients who have undergone percutaneous coronary intervention.
- Patients who have provided written informed consent.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Residual CardioVascular Risk Blood Sample Residual cardiovascular risk is assessed in patients undergoing PCI. Residual CardioVascular Risk DICOM Dataset Residual cardiovascular risk is assessed in patients undergoing PCI.
- Primary Outcome Measures
Name Time Method Net adverse clinical event 3 years post-intervention The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding.
- Secondary Outcome Measures
Name Time Method Nonfatal spontaneous (nonprocedural) myocardial infarction 3 years post-intervention 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 post-intervention 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.
Cardiovascular death 3 years post-intervention 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.
Unplanned hospitalization leading to urgent revascularization 3 years post-intervention 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 post-intervention Bleeding Academic Research Consortium type 3 or 5
V-Angiographic success Within 1 hour post-intervention Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions
V-Complete revascularization Within 1 hour 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 Within 1 hour post-intervention Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions
AI-Complete revascularization Within 1 hour 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, 1 year, 2 years, and 3 years post-intervention This will be measured with P2Y12 reaction units through VerifyNow test.
Thrombogenicity profiles 1 month, 1 year, 2 years, and 3 years post-intervention This will include R, K, Angle, A10, MA, and Ly30 through thromboelastography.
Lipid profiles 1 month, 1 year, 2 years, and 3 years post-intervention This will include total cholesterol, high-density lipoprotein, low-density lipoprotein, and lipoprotein (a).
Hemoglobin A1C 1 month, 1 year, 2 years, and 3 years post-intervention High-sensitivity C-reactive protein 1 month, 1 year, 2 years, and 3 years post-intervention
Trial Locations
- Locations (1)
CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of