Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis

NCT05799092 | Recruiting DMC

• 1 other identifier: SMC2023-02-096-001
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 22

Brief Summary

A pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial. The study will compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) on coronary computed tomography-angiography (CCTA).

Conditions

Coronary Artery Disease

Keywords

Coronary Computed Tomography Angiography; Non-High Risk Obstructive CAD; Diagnostic Approach; Invasive Coronary Angiography; Non-Invasive Functional Test

Outcome Measures

Primary Outcomes (1)

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

  MACE is a composite of death from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.

  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

• Any MI

  2 years after the last patient enrollment

• Spontaneous MI

  2 years after the last patient enrollment

• Procedure-related MI

  2 years after the last patient enrollment

Study Arms (2)

Invasive approach group

EXPERIMENTAL

Invasive coronary angiography will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA..

Diagnostic Test: Invasive coronary angiography

Non-invasive approach group

ACTIVE COMPARATOR

Usual care of non-invasive ischemia testing (exercise electrocardiography \[ECG\], stress echocardiography by exercise or pharmacologic agent, nuclear test including SPECT or PET, stress cardiac magnetic resonance \[MR\]) will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.

Diagnostic Test: Non-invasive functional test

Interventions

Invasive coronary angiography DIAGNOSTIC_TEST

As alternative to non-invasive functional testing, invasive coronary angiography will be performed.

Invasive approach group

Non-invasive functional test DIAGNOSTIC_TEST

Standard non-invasive functional testing will be performed.

Non-invasive approach group

Eligibility Criteria

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

You may qualify if:

• Subject age ≥19 years old
• Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in electrocardiography, regional wall motion abnormality in echocardiography, or coronary calcium score \> 100) suspected for clinically significant CAD who are evaluated by CCTA
• Any other clinical circumstance in which physician judged to proceed CCTA
• Obstructive CAD in CCTA (≥50% diameter stenosis)
• Subject who can verbally confirm understandings of risks, benefits, and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

You may not qualify if:

• Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB)
• High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis)
• Hemodynamically or clinically unstable condition (systolic BP \< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy
• Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)
• Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
• Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.
• Severe left ventricular systolic dysfunction (ejection fraction \<30%)
• Intolerance to Aspirin, Clopidogrel, or Heparin.
• Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
• 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

RECRUITING

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Chungbuk National University Hospital

Chungju, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University

Gwangju, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

RECRUITING

Inje university Ilsan Paik hospital

Ilsan, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

Kwandong University Intl. ST. Mary's Hospital

Incheon, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital, College of Medicine, Hanyang University

Seoul, South Korea

RECRUITING

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-2-3410-3391; drone80@hanmail.net

David Hong, MD

CONTACT

82-2-3410-3391; hongdawi@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: October 2, 2023
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 20, 2025

Record last verified: 2025-11

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)