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.
Study 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).
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
① Patients aged 19 years old
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:
① Advanced chronic kidney disease (Creatinine clearance \<30 ml/min/1.73 m2) not on dialysis
* 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.
Primary outcome measure(s)
Time to first event of major adverse cardiac events (MACE) — 2 years after the last patient enrollment MACE is a composite of death, non-fatal myocardial infarction (MI), hospitalization for acute coronary syndrome leading to an urgent revascularization, or stent thrombosis
Trial sites (22)
Facility
City
Region
Status
SoonChunHyang University Hospital Bucheon
Bucheon-si
South Korea
Not Yet Recruiting
Keimyung University Dongsan Medical Center
Daegu
South Korea
Not Yet Recruiting
Kyungpook National University Hospital
Daegu
South Korea
Recruiting
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju
South Korea
Not Yet Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
South Korea
Not Yet Recruiting
Inje University College of Medicine, Ilsan Paik Hospital
Ilsan
South Korea
Not Yet Recruiting
Gachon University Gil Medical Center
Incheon
South Korea
Not Yet Recruiting
Kwandong University Intl. ST. Mary's Hospital
Incheon
South Korea
Not Yet Recruiting
Jeonbuk National University Hospital
Jeonju
South Korea
Not Yet Recruiting
Gyeongsang National University Hospital
Jinju
South Korea
Not Yet Recruiting
Seoul National University Bundang Hospital
Seongnam-si
South Korea
Not Yet Recruiting
Samsung Medical Center
Seoul
South Korea
Recruiting
Chung-Ang University Hospital, Chung-Ang University College of Medicine
Seoul
South Korea
Not Yet Recruiting
Ewha Womans University Seoul Hospital
Seoul
South Korea
Not Yet Recruiting
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
Seoul
South Korea
Not Yet Recruiting
Korea University Anam Hospital
Seoul
South Korea
Not Yet Recruiting
Korea University Kuro Hospital
Seoul
South Korea
Not Yet Recruiting
Kyung Hee University Medical Center
Seoul
South Korea
Not Yet Recruiting
Seoul National University Boramae Medical Center
Seoul
South Korea
Not Yet Recruiting
Ajou University Hospital
Suwon
South Korea
Not Yet Recruiting
Catholic University of Korea Uijeongbu St. Mary's Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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