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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Residual CardioVascular Risk | Residual cardiovascular risk is assessed in patients undergoing PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years after the 1-month assessment (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing PCI
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Yul Lee, MD | CHA Bundang Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32478100 | Background | 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. | |
| 17470709 | Background | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| DICOM Dataset | Other | Patients' DICOM dataset is evaluated using artificial intelligence-based quantitative coronary analysis to assess a procedural risk. |
|
| 3 years after the 1-month assessment (baseline) |
| 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. | 3 years after the 1-month assessment (baseline) |
| 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. | 3 years after the 1-month assessment (baseline) |
| 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. | 3 years after the 1-month assessment (baseline) |
| Major bleeding | Bleeding Academic Research Consortium type 3 or 5 | 3 years after the 1-month assessment (baseline) |
| V-Angiographic success | Participant with visually estimated residual diameter stenosis of less than 20% in all PCI-treated lesions | 1 month post-intervention |
| 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 | 1 month post-intervention |
| AI-Angiographic success | Participant with artificial intelligence-measured residual diameter stenosis of less than 20% in all PCI-treated lesions | 1 month post-intervention |
| 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 | 1 month post-intervention |
| Platelet reactivity | This will be measured with P2Y12 reaction units through VerifyNow test. | 1 month post-intervention |
| Thrombogenicity profiles | 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 | 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 | 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 |
| 21670242 | Background | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |