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

Sponsor

Samsung Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799092

Collaborator

(none)

2,000

Enrollment

Location

Arms

Anticipated Duration (Months)

21.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Diagnostic Test: Invasive coronary angiography Diagnostic Test: Non-invasive functional test	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2029

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Invasive approach group 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 As alternative to non-invasive functional testing, invasive coronary angiography will be performed.
Active Comparator: Non-invasive approach group 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 Standard non-invasive functional testing will be performed.

Arm

Intervention/Treatment

Experimental: Invasive approach group

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

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

Active Comparator: Non-invasive approach group

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

Standard non-invasive functional testing will be performed.

Outcome Measures

Primary Outcome Measures

Time to first event of major adverse cardiac events (MACE) [2 years after the last patient enrollment]
MACE is a composite of death from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.

Secondary Outcome Measures

All-cause death [2 years after the last patient enrollment]
All-cause death
Cardiac death [2 years after the last patient enrollment]
Cardiac death
Any MI [2 years after the last patient enrollment]
Defined by Forth Universal definition of MI
Spontaneous MI [2 years after the last patient enrollment]
Defined by Forth Universal definition of MI
Procedure-related MI [2 years after the last patient enrollment]
Defined by ARC II definition
Resuscitated cardiac arrest [2 years after the last patient enrollment]
Resuscitated cardiac arrest
Unplanned revascularization (clinically driven) [2 years after the last patient enrollment]
Unplanned revascularization (clinically driven)
Rate of index coronary angiography [up to 30 days following randomization]
Rate of index coronary angiography
Rate of index revascularization by PCI or CABG [up to 30 days following randomization]
Rate of index revascularization by PCI or CABG
European Quality of Life-5 Dimensions [6 months after initial management according to allocated diagnostic test]
European Quality of Life-5 Dimensions
Seattle Angina Questionnaire [6 months after initial management according to allocated diagnostic test]
Seattle Angina Questionnaire
Total medical cost [2 years after the last patient enrollment]
Total medical cost
Procedure-related complications from invasive procedure [up to 30 days following randomization]
Procedure-related complications from invasive procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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) suspicious 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.

Exclusion Criteria:

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.