DSE vs Invasive FFR vs CT-FFR

Study Overview
=================
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.

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 FFR≤0,8 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.

Official Title
-----------------
Assessment of NOn-culprit Lesions With dobutamiNe Stress eChocardiography, compUted Tomography and Fractional fLow Reserve in Patients With Acute

Conditions
-----------------
Fractional Flow Reserve

Intervention / Treatment
-----------------
* Procedure: Revascularization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute myocardial infarction Moderate (40-80 %) stenosis of a non-culprit coronary artery Signed informed consent Exclusion Criteria: Age under 18 years Age over 80 years Incurable malignant disease Patients for whom coronary CTA is contraindicated (History of severe and/or anaphylactic contrast reaction, severe renal insufficiency, inability to cooperate with scan acquisition and/or breathhold instructions)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 PCI Group<br>Patients after acute myocardial infarction and at least one moderate stenosis on the non-culprit vessels with positive dobutamine stress echocardiography and positive Fractional Flow Reserve recieving revascularization (PCI or CABG) Drug: Standard of care after acute myocardial infarction | Procedure: Revascularization<br>* PCI or CABG<br>|
| Group 2 OMT group<br>Patients after acute myocardial infarction and at least one moderate stenosis on the non-culprit vessels with negative dobutamine stress echocardiography and negative Fractional Flow Reserve or the mismatching cases Standard of care after acute myocardial infarction | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute myocardial infarction | Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB). | From baseline to at least 2 years | 
| Cardiovascular death | Death occurs due to cardiovascular cause | From baseline to at least 2 years | 
| Target vessel revascularization | The Investigated Vessel needs Revascularisation due to angina | From baseline to at least 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of CT-FFR vs invasive FFR | Diagnostic performance of CT-FFR as compared to invasive FFR | From baseline to 3 months | 
| Diagnostic performance of CT-FFR vs DSE | Diagnostic performance of CT-FFR as compared to DSE | From baseline to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dobutamine stress echocardiography, Fractional flow reserve, Computed tomography-fractional flow reserve, Non-culprit lesions, Myocardial infarction, Lesion specific ischemia