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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Invasive coronary angiography
Non-invasive functional test
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Computed Tomography Angiography, Non-High Risk Obstructive CAD, Diagnostic Approach, Invasive Coronary Angiography, Non-Invasive Functional Test

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Invasive approach group

Non-invasive approach group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All-cause death
All-cause death
Cardiac death
Cardiac death
Any MI
Defined by Forth Universal definition of MI
Spontaneous MI
Defined by Forth Universal definition of MI
Procedure-related MI
Defined by ARC II definition
Resuscitated cardiac arrest
Resuscitated cardiac arrest
Unplanned revascularization (clinically driven)
Unplanned revascularization (clinically driven)
Rate of index coronary angiography
Rate of index coronary angiography
Rate of index revascularization by PCI or CABG
Rate of index revascularization by PCI or CABG
European Quality of Life-5 Dimensions
European Quality of Life-5 Dimensions
Seattle Angina Questionnaire
Seattle Angina Questionnaire
Total medical cost
Total medical cost
Procedure-related complications from invasive procedure
Procedure-related complications from invasive procedure

Full Information

First Posted
March 22, 2023
Last Updated
October 4, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05799092
Brief Title
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
Acronym
SMART-STEP
Official Title
Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
June 30, 2029 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Computed Tomography Angiography, Non-High Risk Obstructive CAD, Diagnostic Approach, Invasive Coronary Angiography, Non-Invasive Functional Test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.
Masking
Outcomes Assessor
Masking Description
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Invasive approach group
Arm Type
Experimental
Arm Description
Invasive coronary angiography will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA..
Arm Title
Non-invasive approach group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Invasive coronary angiography
Intervention Description
As alternative to non-invasive functional testing, invasive coronary angiography will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Non-invasive functional test
Intervention Description
Standard non-invasive functional testing will be performed.
Primary Outcome Measure Information:
Title
Time to first event of major adverse cardiac events (MACE)
Description
MACE is a composite of death from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.
Time Frame
2 years after the last patient enrollment
Secondary Outcome Measure Information:
Title
All-cause death
Description
All-cause death
Time Frame
2 years after the last patient enrollment
Title
Cardiac death
Description
Cardiac death
Time Frame
2 years after the last patient enrollment
Title
Any MI
Description
Defined by Forth Universal definition of MI
Time Frame
2 years after the last patient enrollment
Title
Spontaneous MI
Description
Defined by Forth Universal definition of MI
Time Frame
2 years after the last patient enrollment
Title
Procedure-related MI
Description
Defined by ARC II definition
Time Frame
2 years after the last patient enrollment
Title
Resuscitated cardiac arrest
Description
Resuscitated cardiac arrest
Time Frame
2 years after the last patient enrollment
Title
Unplanned revascularization (clinically driven)
Description
Unplanned revascularization (clinically driven)
Time Frame
2 years after the last patient enrollment
Title
Rate of index coronary angiography
Description
Rate of index coronary angiography
Time Frame
up to 30 days following randomization
Title
Rate of index revascularization by PCI or CABG
Description
Rate of index revascularization by PCI or CABG
Time Frame
up to 30 days following randomization
Title
European Quality of Life-5 Dimensions
Description
European Quality of Life-5 Dimensions
Time Frame
6 months after initial management according to allocated diagnostic test
Title
Seattle Angina Questionnaire
Description
Seattle Angina Questionnaire
Time Frame
6 months after initial management according to allocated diagnostic test
Title
Total medical cost
Description
Total medical cost
Time Frame
2 years after the last patient enrollment
Title
Procedure-related complications from invasive procedure
Description
Procedure-related complications from invasive procedure
Time Frame
up to 30 days following randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Myung Lee, MD, MPH, PhD
Phone
82-2-3410-3391
Email
drone80@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
David Hong, MD
Phone
82-2-3410-3391
Email
hongdawi@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
Phone
82-2-3410-2575
Email
drone80@hanmail.net
First Name & Middle Initial & Last Name & Degree
David Hong, MD
Phone
82-2-3410-2575
Email
hongdawi@naver.com
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
First Name & Middle Initial & Last Name & Degree
David Hong, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Time Frame
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Access Criteria
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Learn more about this trial

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

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