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

Last updated: March 12, 2025
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Thrombosis

Vascular Diseases

Treatment

Invasive coronary angiography

Non-invasive functional test

Clinical Study ID

NCT05799092
SMC2023-02-096-001
  • Ages > 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject age ≥19 years old

  2. Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormallaboratory test findings (suspected ischemic changes in electrocardiography,regional wall motion abnormality in echocardiography, or coronary calcium score >

  1. suspected for clinically significant CAD who are evaluated by CCTA

  1. Any other clinical circumstance in which physician judged to proceed CCTA

  2. Obstructive CAD in CCTA (≥50% diameter stenosis)

  3. Subject who can verbally confirm understandings of risks, benefits, and treatmentalternatives of receiving invasive approach and he/she or his/her legally authorizedrepresentative provides written informed consent prior to any study relatedprocedure.

Exclusion

Exclusion Criteria:

  1. Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization orurgent or emergent testing (elevated cardiac troponin or CK-MB)

  2. High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel diseasewith ≥70% stenosis)

  3. Hemodynamically or clinically unstable condition (systolic BP < 90 mmHg, ventriculararrhythmias, or persistent resting chest pain in ischemic nature despite adequatetherapy

  4. Known CAD with previous MI, percutaneous coronary intervention (PCI), coronaryartery bypass graft (CABG)

  5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylacticshock)

  6. Known significant congenital, severe valvular or cardiomyopathic (hypertrophic ordilated cardiomyopathy, or any other forms) process which could explain cardiacsymptoms.

  7. Severe left ventricular systolic dysfunction (ejection fraction <30%)

  8. Intolerance to Aspirin, Clopidogrel, or Heparin.

  9. Non-cardiac co-morbid conditions are present with life expectancy <2 year or thatmay result in protocol non-compliance (per site investigator's medical judgment)

  10. Unwillingness or inability to comply with the procedures described in this protocol.

Study Design

Total Participants: 2000
Treatment Group(s): 2
Primary Treatment: Invasive coronary angiography
Phase:
Study Start date:
October 02, 2023
Estimated Completion Date:
December 31, 2030

Study Description

CCTA has been emerged as useful diagnostic tool to evaluate CAD. Besides high diagnostic accuracy, CCTA has additional benefit of measuring the cumulative atherosclerotic burden and more accurately discriminating obstructive CAD with additional fractional flow reserve by CT (FFRCT), making it more predictive of a patient's prognosis. Recently, several randomized clinical trials have demonstrated the clinical utility of CCTA when compared with noninvasive stress test, which has been previously widely used as an initial assessment for stable chest pain, or invasive coronary angiography, which is the gold standard for diagnosing obstructive CAD.

On this background, CCTA, along with stress imaging test, is recommended as first step to diagnose obstructive CAD in patients with intermediate to high pretest probabilities with stable chest pain and is increasingly utilized. Although CCTA is increasingly used as initial assessment tool in these patients, there are insufficient studies to clearly establish the next step after obstructive CAD is confirmed in CCTA. Without high-risk features of CAD on CCTA, current guidelines suggest noninvasive stress imaging or FFRCT as class IIA recommendation. However, supporting evidence of these suggestions are mostly based on studies with low level of evidence. Furthermore, given the limited diagnostic performance of noninvasive stress test, concern remains whether it is safe to defer invasive coronary angiography based on the result from noninvasive stress test in patients with obstructive CAD on CCTA.

Therefore, this trial aims to compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.

Connect with a study center

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

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