Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07009418
Brief Summary:
The aim of the SMART-CARE trial is to compare clinical outcomes between coronary CT angiography (CCTA) versus standard care as follow-up strategies in high-risk patients after percutaneous coronary intervention (PCI).
Detailed Description:
Advancements in drug-eluting stents, physiology-guided treatment decisions, intravascular imaging-guided procedural optimization, and adjunctive medical therapy have significantly improved prognosis after percutaneous coronary intervention (PCI). However, high-risk patients-particularly those with complex coronary artery lesions or high-risk clinical conditions such as acute myocardial infarction with or without cardiogenic shock at presentation, diabetes mellitus which requires medical treatment (oral hypoglycemic agents or insulin), end-stage renal disease under dialysis, or multi-vascular disease-continue to have a significantly higher risk of adverse cardiovascular events. In this regard, meticulous follow-up, including periodic assessment of clinical and functional status, guideline-directed medical therapy (GDMT), and secondary prevention strategies are important, and current guidelines strongly recommend these measures as a Class I recommendation. However, recent randomized controlled trials have demonstrated that high-risk patients with complex coronary artery disease or high-risk clinical conditions still experience a continuous increase in adverse cardiovascular events despite optimal secondary prevention. This underscores the need for an optimized surveillance strategy to improve long-term prognosis.
Despite the emphasis on GDMT and secondary prevention in current guidelines, the most effective surveillance strategy after PCI remains uncertain. Existing recommendations primarily address secondary prevention and provide only limited guidance on surveillance for patients with previous coronary revascularization. Based on multiple randomized controlled trials, current guidelines do not recommend routine non-invasive stress testing or coronary CT angiography (CCTA) in asymptomatic patients receiving optimized GDMT (Class III, Level of Evidence B-R). However, this recommendation lacks direct evidence evaluating CCTA as a surveillance strategy after PCI. In patients with prior coronary revascularization, CCTA is currently recommended for assessing bypass graft or stent patency only in symptomatic patients (Class IIa), with limited supporting evidence (Level of Evidence B in ESC guidelines and Level of Evidence B-NR in ACC/AHA guidelines).
Notably, the SCOT-HEART trial demonstrated that a CCTA-based treatment strategy was superior to standard care, which relied on clinical and functional assessment along with as-needed non-invasive stress testing, in reducing a composite outcome of coronary heart disease death and non-fatal myocardial infarction. This suggests that a surveillance strategy incorporating CCTA may lead to improved subsequent management decisions, such as preemptive ischemia-driven revascularization or intensified medical therapy, potentially reducing ischemic cardiovascular events and mortality compared to standard guideline-recommended care.
To address this critical gap in clinical practice, we designed the Smart Angioplasty Research Team-Coronary CT Angiography versus Standard Care as Follow-up Strategies in High-Risk Patients after PCI (SMART-CARE) trial. This study aims to evaluate the impact of a CCTA-based surveillance strategy on clinical outcomes compared with standard guideline-directed follow-up in high-risk patients who have undergone PCI.
Study:
NCT07009418
Study Brief:
Protocol Section:
NCT07009418