Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE)
NCT ID: NCT07009418
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3500 participants
INTERVENTIONAL
2025-10-02
2032-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Surveillance by CCTA Strategy Group
In the surveillance by CCTA group, patients will be evaluated by CCTA at 1 year from index hospitalization. CCTA will be done according to current acquisition guidelines.
Coronary CT Angiography (CCTA)
In the surveillance by CCTA group, patients will be evaluated by CCTA at 1 year from index hospitalization. CCTA will be done according to current acquisition guidelines. Downstream management according to the results from CCTA will be performed under recommendations from current guidelines.
Standard Care Strategy Group
In the standard care group, patients will be managed according to the current guidelines. Regardless of symptoms, periodic visits will be performed by the charged physician. Secondary prevention including cardiovascular risk factor control, assessment of disease status, and comorbidities, and GDMT will be meticulously performed. In patients without a change in clinical or functional status, further evaluation by CCTA or non-invasive functional tests will not be performed. In this group, CCTA or non-invasive functional tests will be performed only for patients with significant change in clinical or functional status or with symptoms refractory to medical treatment.6,8 Whether patients will be referred for invasive coronary angiography will be determined by the charged physician according to patient's clinical or functional status and the results from CCTA or non-invasive functional tests according to current guidelines.
No interventions assigned to this group
Interventions
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Coronary CT Angiography (CCTA)
In the surveillance by CCTA group, patients will be evaluated by CCTA at 1 year from index hospitalization. CCTA will be done according to current acquisition guidelines. Downstream management according to the results from CCTA will be performed under recommendations from current guidelines.
Eligibility Criteria
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Inclusion Criteria
② Patients who underwent successful PCI with one or more contemporary drug-eluting stents (stent diameter ≥3mm) or drug-coated balloons.
③ Patients must have at least one of the following criteria of complex coronary artery lesions or high-risk clinical characteristics:
A. Complex coronary artery lesions:
i. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size ii. Chronic total occlusion (≥3 months) as target lesion iii. PCI for unprotected left main (LM) disease (LM ostium, body, distal LM bifurcation including non-true bifurcation) iv. Long coronary lesions (used stents or drug-coated balloons ≥38 mm in length) v. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session) vi. Multiple devices needed (≥3 more stents or drug-coated balloons per patient) vii. In-stent restenosis lesion as target lesion viii. Severely calcified lesion (encircling calcium in angiography) ix. Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion
B. High-risk clinical characteristics:
i. Acute myocardial infarction (ST-elevation myocardial infarction \[MI\] or non-ST-elevation MI) with or without cardiogenic shock (SCAI Classification ≥C) at presentation ii. Diabetes mellitus which requires medical treatment (oral hypoglycemic agents or insulin) iii. End-stage renal disease under dialysis iv. Combined vascular disease other than coronary artery disease
1. Peripheral artery occlusive disease which is defined as A. Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or B. Previous limb or foot amputation for arterial vascular disease, or C. History of intermittent claudication and one or more of the following: 1) An ankle/arm blood pressure (BP) ratio \< 0.90, or 2) Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound, or D. Previous carotid revascularization or asymptomatic carotid artery stenosis ≥50% as diagnosed by duplex ultrasound or angiography.
2. Thoracoabdominal aortic disease which is defined as A. Documented thoracoabdominal aortic aneurysm by duplex ultrasound, angiography, or computed tomography angiography B. Previous endovascular or surgical treatment for thoracoabdominal aortic aneurysm
④ Subject who can verbally confirm understandings of risks, benefits and surveillance strategy alternatives of receiving CCTA and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria
* Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
* Pregnancy or breast feeding ④ Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) ⑤ Unwillingness or inability to comply with the procedures described in this protocol.
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Joo Myung Lee
Associate Professor
Principal Investigators
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Joo Myung Lee, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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SoonChunHyang University Hospital Bucheon
Bucheon-si, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
Inje University College of Medicine, Ilsan Paik Hospital
Ilsan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Kwandong University Intl. ST. Mary's Hospital
Incheon, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Samsung Medical Center
Seoul, , South Korea
Chung-Ang University Hospital, Chung-Ang University College of Medicine
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Kuro Hospital
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jon Suh, MD, PhD
Role: primary
Hyuck Jun Yoon, MD, PhD
Role: primary
Namkyun Kim, MD, PhD
Role: primary
Seung Hun Lee, MD, PhD
Role: primary
Young Joon Hong, MD, PhD
Role: backup
Jinhwan Jo, MD, PhD
Role: primary
Sung Woo Cho, MD, PhD
Role: primary
Albert Youngwoo Jang, MD, PhD
Role: primary
Hyung-Bok Park, MD, PhD
Role: primary
Yisik Kim, MD, PhD
Role: primary
Jin Sin Koh, MD, PhD
Role: primary
Ki-Hyun Jeon, MD, PhD
Role: primary
Joo Myung Lee, MD, MPH, PhD
Role: primary
Kyung-Taek Park, MD, PhD
Role: primary
Sang Hoon Shin, MD, PhD
Role: primary
Young-Hyo Lim, MD, PhD
Role: primary
Soon-Jun Hong, MD, PhD
Role: primary
Dong-Oh Kang, MD, PhD
Role: primary
Jong-Shin Woo, MD, PhD
Role: primary
Hyun Sung Joh, MD, PhD
Role: primary
Hong-Seok Lim, MD,PhD
Role: primary
Chan Joon Kim, MD, PhD
Role: primary
Jung-Hee Lee, MD, PhD
Role: primary
Other Identifiers
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SMC19801001
Identifier Type: -
Identifier Source: org_study_id