Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988881
Status:
UNKNOWN
Last Update Posted:
2019-06-18
First Post:
2018-11-07
Brief Title:
DSE vs Invasive FFR vs CT-FFR
Sponsor:
Semmelweis University Heart and Vascular Center
Organization:
Semmelweis University Heart and Vascular Center
Study Overview
Official Title:
Assessment of NOn-culprit Lesions With dobutamiNe Stress eChocardiography compUted Tomography and Fractional fLow Reserve in Patients With Acute
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
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:
NON-CULPRIT
Brief Summary:
Data are limited regarding the optimal treatment of the non-culprit lesions NCL after myocardial infarction MI The NON-CULPRIT study is a prospective cohort study with a primary aim to compare invasive fractional flow reserve FFR and dobutamine stress echocardiography DSE for the evaluation and treatment of NCL in patients with MI
As a secondary aim the investigators will assess the diagnostic performance of CT derived FFR as compared to invasive FFR and DSE measurements
As a secondary aim the investigators will assess the diagnostic performance of CT derived FFR as compared to invasive FFR and DSE measurements
Detailed Description:
Myocardial ischemia and coronary artery disease CAD burden both provide valuable prognostic information for adverse cardiac events More than 50 of patients with acute myocardial infarction have multi-vessel coronary artery disease However current evidence regarding the optimal treatment of the non-culprit lesions NCL after myocardial infarction MI is still limited
The revascularization of NCL with at least moderate severity is associated with improved clinical outcomes if significant ischemia was detected previously Currently there is no strict recommendation on the methods for detecting ischemia therefore the current study aims to compare Dobutamine stress echocardiography DSE and invasive FFR for the evaluation and management of patients with MI and multi-vessel disease
DSE and FFR measurements will be perfomed in patinets with at least one intermediate NCL If both results are positive new wall motion abnormality of at least two segments related to the examined coronary artery on DSE and FFR08 are declared as positive stent implantation will be performed if both results are negative or in case of mismatch optimal medical treatment will be chosen
Recent studies demonstrated the discrepancy between anatomical severity and hemodynamic relevance Invasive fractional flow reserve FFR has emerged as the gold standard technique for the detection of lesion specific ischemia The utilization of FFR in stable and acute chest pain patients can help in the selection of proper treatment strategy The recently published Compare-Acute and DANAMI-Primulti trials have shown that in STEMI patients FFR-guided complete revascularization of NCL is beneficial as compared to infarct related lesion revascularization only
However in light of recent studies involving post-MI patients invasive FFR might be limited for the assessment of NCL due to vessel remodeling microvascular changes and altered hemodynamics
Recent advancements in CT imaging allows for improved image quality and novel post-processing algorithms Beyond anatomical data functional information using coronary CT angiography CTA dataset and computational fluid dynamics simulations can be derived CT derived FFR allows for the functional assessment of CAD in a non-invasive fashion
Data regarding the diagnostic accuracy of CT-FFR as compared to other widely utilized functional tests are limited Also high-risk plaque features might affect lesion specific ischemia as detected by invasive FFR Coronary CTA plus CT-FFR may help to identify patients requiring revascularization even with controversial DSE and FFR results
The revascularization of NCL with at least moderate severity is associated with improved clinical outcomes if significant ischemia was detected previously Currently there is no strict recommendation on the methods for detecting ischemia therefore the current study aims to compare Dobutamine stress echocardiography DSE and invasive FFR for the evaluation and management of patients with MI and multi-vessel disease
DSE and FFR measurements will be perfomed in patinets with at least one intermediate NCL If both results are positive new wall motion abnormality of at least two segments related to the examined coronary artery on DSE and FFR08 are declared as positive stent implantation will be performed if both results are negative or in case of mismatch optimal medical treatment will be chosen
Recent studies demonstrated the discrepancy between anatomical severity and hemodynamic relevance Invasive fractional flow reserve FFR has emerged as the gold standard technique for the detection of lesion specific ischemia The utilization of FFR in stable and acute chest pain patients can help in the selection of proper treatment strategy The recently published Compare-Acute and DANAMI-Primulti trials have shown that in STEMI patients FFR-guided complete revascularization of NCL is beneficial as compared to infarct related lesion revascularization only
However in light of recent studies involving post-MI patients invasive FFR might be limited for the assessment of NCL due to vessel remodeling microvascular changes and altered hemodynamics
Recent advancements in CT imaging allows for improved image quality and novel post-processing algorithms Beyond anatomical data functional information using coronary CT angiography CTA dataset and computational fluid dynamics simulations can be derived CT derived FFR allows for the functional assessment of CAD in a non-invasive fashion
Data regarding the diagnostic accuracy of CT-FFR as compared to other widely utilized functional tests are limited Also high-risk plaque features might affect lesion specific ischemia as detected by invasive FFR Coronary CTA plus CT-FFR may help to identify patients requiring revascularization even with controversial DSE and FFR results
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