Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05799092
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-03-22
Brief Title:
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis SMART-STEP Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMART-STEP
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
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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None