Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE) (SMART-CARE)

December 14, 2025 updated by: Joo Myung Lee, Samsung Medical Center

Coronary Computed Tomography Angiography Versus Standard Care in High-Risk Patients After Percutaneous Coronary Intervention

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Bucheon-si, South Korea
        • Not yet recruiting
        • Soonchunhyang University Hospital Bucheon
        • Contact:
        • Principal Investigator:
          • Jon Suh, MD, PhD
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
        • Principal Investigator:
          • Namkyun Kim, MD, PhD
        • Sub-Investigator:
          • Jang Hoon Lee, MD, PhD
      • Daegu, South Korea
        • Not yet recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Principal Investigator:
          • Hyuck Jun Yoon, MD, PhD
      • Gwangju, South Korea
        • Not yet recruiting
        • Chonnam National University Hospital, Chonnam National University Medical School
        • Contact:
        • Sub-Investigator:
          • Seung Hun Lee, MD, PhD
        • Contact:
        • Principal Investigator:
          • Young Joon Hong, MD, PhD
        • Sub-Investigator:
          • Jun Ho Ahn, MD, PhD
      • Gwangmyeong, South Korea
        • Not yet recruiting
        • Chung-Ang University Gwangmyeong Hospital
        • Contact:
        • Principal Investigator:
          • Jinhwan Jo, MD, PhD
        • Sub-Investigator:
          • Sang Yeub Lee, MD, PhD
        • Sub-Investigator:
          • Jun Hwan Cho, MD, PhD
      • Ilsan, South Korea
        • Not yet recruiting
        • Inje University College of Medicine, Ilsan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Sung Woo Cho, MD, PhD
        • Sub-Investigator:
          • Sung-Eun Kim, MD, PhD
        • Sub-Investigator:
          • Hyun Cho, MD, PhD
      • Incheon, South Korea
        • Not yet recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Albert Youngwoo Jang, MD, PhD
      • Incheon, South Korea
        • Not yet recruiting
        • Kwandong University Intl. ST. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Hyung-Bok Park, MD, PhD
      • Jeonju, South Korea
        • Not yet recruiting
        • Jeonbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Yisik Kim, MD, PhD
        • Sub-Investigator:
          • Chang Hoon Kim, MD, PhD
      • Jinju, South Korea
        • Not yet recruiting
        • Gyeongsang National University Hospital
        • Sub-Investigator:
          • Min Gyu Kang, MD, PhD
        • Contact:
        • Principal Investigator:
          • Jin Sin Koh, MD, PhD
        • Sub-Investigator:
          • Hangyul Kim, MD, PhD
      • Seongnam-si, South Korea
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Ki-Hyun Jeon, MD, PhD
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Joo Myung Lee, MD, MPH, PhD
        • Contact:
        • Sub-Investigator:
          • Taek Kyu Park, MD, PhD
        • Sub-Investigator:
          • Jeong Hoon Yang, MD, PhD
        • Sub-Investigator:
          • Young Bin Song, MD, PhD
        • Sub-Investigator:
          • Ki-Hong Choi, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Soon-Jun Hong, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
        • Principal Investigator:
          • Sang Hoon Shin, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Chung-Ang University Hospital, Chung-Ang University College of Medicine
        • Contact:
        • Principal Investigator:
          • Kyung-Taek Park, MD, PhD
        • Sub-Investigator:
          • Ho Youn Won, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Hanyang University Seoul Hospital, College of Medicine, Hanyang University
        • Contact:
        • Principal Investigator:
          • Young-Hyo Lim, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Korea University Kuro Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Oh Kang, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Kyung Hee University Medical Center
        • Contact:
        • Principal Investigator:
          • Jong-Shin Woo, MD, PhD
        • Sub-Investigator:
          • Weon Kim, MD, PhD
      • Seoul, South Korea
        • Not yet recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Sung Joh, MD, PhD
      • Suwon, South Korea
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • Hong-Seok Lim, MD,PhD
      • Uijeongbu-si, South Korea
        • Not yet recruiting
        • Catholic University of Korea Uijeongbu St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Chan Joon Kim, MD, PhD
        • Sub-Investigator:
          • Seonghyeon Bu, MD, PhD
      • Wŏnju, South Korea
        • Not yet recruiting
        • Wonju Severance Christian Hospital
        • Contact:
        • Principal Investigator:
          • Jung-Hee Lee, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first event of major adverse cardiac events (MACE)
Time Frame: 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
2 years after the last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 2 years after the last patient enrollment
All-cause death
2 years after the last patient enrollment
Cardiac death
Time Frame: 2 years after the last patient enrollment
Cardiac death
2 years after the last patient enrollment
Total medical cost
Time Frame: 2 years after the last patient enrollment
Total medical cost
2 years after the last patient enrollment
Cerebrovascular accidents
Time Frame: 2 years after the last patient enrollment
Cerebrovascular accidents (ischemic or hemorrhagic)
2 years after the last patient enrollment
Non-fatal MI
Time Frame: 2 years after the last patient enrollment
Non-fatal MI, defined by Forth Universal definition of MI
2 years after the last patient enrollment
Spontaneous MI
Time Frame: 2 years after the last patient enrollment
Spontaneous MI, defined by Forth Universal definition of MI
2 years after the last patient enrollment
Hospitalization for acute coronary syndrome leading to an urgent revascularization
Time Frame: 2 years after the last patient enrollment
Hospitalization for acute coronary syndrome is defined as a clinical event in which the final diagnosis during unplanned hospitalization is acute coronary syndrome including spontaneous myocardial infarction or unstable angina.
2 years after the last patient enrollment
Unplanned revascularization (clinically-driven)
Time Frame: 2 years after the last patient enrollment

All revascularization events will be adjudicated as either clinically-driven or non-clinically-driven. Revascularization will be considered clinically-driven if the diameter stenosis of the revascularized coronary segment is ≥50% by QCA and any of the following criteria for ischemia are met:

  • A positive functional study corresponding to the area served by the target lesion; or

    • Ischemic ECG changes at rest in a distribution consistent with the target vessel; or

      • Typical ischemic symptoms referable to the target lesion; or ④ positive invasive physiologic test (fractional flow reserve ≤0.80 or instantaneous wave-free ratio ≤0.89); or ⑤ presence of stenosis with ≥70% diameter stenosis, even in the absence of other criteria Unplanned revascularization refers to revascularization not planned after initial assessments with invasive coronary angiography or non-invasive stress testing, depending on the allocated group, but performed due to clinical circumstances.
2 years after the last patient enrollment
Definite stent thrombosis
Time Frame: 2 years after the last patient enrollment
Definite stent thrombosis, defined by Academic Research Consortium (ARC) II consensus
2 years after the last patient enrollment
Rate of invasive coronary angiography during follow-up
Time Frame: 2 years after the last patient enrollment

Rate of invasive coronary angiography (with or without showing restenosis or obstructive CAD) during follow-up.

Angiographic restenosis was defined as a stenosis of at least 50 percent of the minimal luminal diameter in the target-lesion at invasive coronary angiography during follow-up. Obstructive or no obstructive coronary artery disease at invasive coronary angiography is defined as a visually estimated presence or absence of stenosis of 50% or more, as interpreted by the study-site staff, in any major epicardial vessel, including side branches of at least 2.5 mm in diameter.
2 years after the last patient enrollment
Rate of revascularization by PCI or CABG during follow-up
Time Frame: 2 years after the last patient enrollment
Rate of revascularization by PCI or CABG during follow-up
2 years after the last patient enrollment
Procedure-related complications from invasive procedure during follow-up
Time Frame: 2 years after the last patient enrollment
Procedure-related complications from invasive procedure during follow-up
2 years after the last patient enrollment
Contrast-induced nephropathy or contrast-associated hypersensitivity reaction
Time Frame: 2 years after the last patient enrollment
Contrast-induced nephropathy, defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure or contrast-associated hypersensitivity reaction
2 years after the last patient enrollment
A composite of death or non-fatal MI
Time Frame: 2 years after the last patient enrollment
A composite of death or non-fatal MI
2 years after the last patient enrollment
Procedure-related MI (during follow-up period from invasive procedure)
Time Frame: 2 years after the last patient enrollment
Procedure-related MI (during follow-up period from invasive procedure), defined by Fourth Universal definition of MI
2 years after the last patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

May 29, 2025

First Submitted That Met QC Criteria

May 29, 2025

First Posted (Actual)

June 6, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC19801001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

IPD Sharing Time Frame

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

IPD Sharing Access Criteria

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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