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

NCT07009418 | Recruiting DMC

• 1 other identifier: SMC19801001
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 22

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).

Conditions

Coronary Artery Disease; Ischemic Heart Disease

Keywords

coronary artery disease; percutaneous coronary intervention; coronary computed tomography angiography; follow-up strategy

Outcome Measures

Primary Outcomes (1)

• Time to first event of major adverse cardiac events (MACE)

  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 Outcomes (15)

• All-cause death

  2 years after the last patient enrollment

• Cardiac death

  2 years after the last patient enrollment

• Non-fatal MI

  2 years after the last patient enrollment

• Spontaneous MI

  2 years after the last patient enrollment

• Procedure-related MI (during follow-up period from invasive procedure)

  2 years after the last patient enrollment

Study Arms (2)

Surveillance by CCTA Strategy Group

EXPERIMENTAL

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)

Standard Care Strategy Group

NO INTERVENTION

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.

Interventions

Coronary CT Angiography (CCTA) DIAGNOSTIC_TEST

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.

Surveillance by CCTA Strategy Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (22)

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, 06351, 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

Uijeongbu-si, South Korea

NOT YET RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

+82234102575; drone80@hanmail.net

Ki-Hong Choi, MD, PhD

CONTACT

+82234102575; cardiokh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant and care provider cannot be blinded. But, investigator and clinical outcoem assessor will be blinded about the randomly allocated groups. Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
• Access Criteria: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

Locations

KR (22)