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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Republic of Korea
SoonChunHyang University Hospital Bucheon
NOT_YET_RECRUITING
Bucheon-si
Keimyung University Dongsan Medical Center
NOT_YET_RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Chonnam National University Hospital, Chonnam National University Medical School
NOT_YET_RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
NOT_YET_RECRUITING
Gwangmyeong
Inje University College of Medicine, Ilsan Paik Hospital
NOT_YET_RECRUITING
Ilsan
Gachon University Gil Medical Center
NOT_YET_RECRUITING
Incheon
Kwandong University Intl. ST. Mary's Hospital
NOT_YET_RECRUITING
Incheon
Jeonbuk National University Hospital
NOT_YET_RECRUITING
Jeonju
Gyeongsang National University Hospital
NOT_YET_RECRUITING
Jinju
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam-si
Chung-Ang University Hospital, Chung-Ang University College of Medicine
NOT_YET_RECRUITING
Seoul
Ewha Womans University Seoul Hospital
NOT_YET_RECRUITING
Seoul
Hanyang University Seoul Hospital, College of Medicine, Hanyang University
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Korea University Kuro Hospital
NOT_YET_RECRUITING
Seoul
Kyung Hee University Medical Center
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Ajou University Hospital
NOT_YET_RECRUITING
Suwon
Catholic University of Korea Uijeongbu St. Mary's Hospital
NOT_YET_RECRUITING
Uijeongbu-si
Wonju Severance Christian Hospital
NOT_YET_RECRUITING
Wŏnju
Contact Information
Primary
Joo Myung Lee, MD, MPH, PhD
drone80@hanmail.net
+82234102575
Backup
Ki-Hong Choi, MD, PhD
cardiokh@gmail.com
+82234102575
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 3500
Treatments
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.
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.
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov