Instantaneous Wave-free Ratio Guidance Strategy Evaluation in the Treatment of Multivessel Acute Coronary Syndrome.

Study Overview
=================
Brief Summary
-----------------
A single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (iFR) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (ACS) patients.

Detailed Description
-----------------
The all-comers study population consists of hemodynamically stable de novo ACS patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 and willing to sign a patient informed consent. ACS diagnosis established by angina pectoris symptoms and/or ECG changes and/or hs-troponin I levels. The use of drug-eluting stents is mandatory in both treatment groups. In the intervention strategy group, patients are treated by the iFR-guided percutaneous coronary intervention (PCI) in one stage. In the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.

Official Title
-----------------
Characterization of Coronary Artery Hemodynamic Measurements and Virtual Angioplasty Planning by Instantaneous Wave-free Ratio (iFR) in Multivessel Acute Coronary Syndrome Patients With Evaluation of the Impact on Clinical Outcomes.

Conditions
-----------------
Cardiac Ischemia, Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older willing to give informed consent hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries adequate coronary flow, Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 2 sinus rhythm Exclusion Criteria: inability to give consent; younger than 18 years of age atrial fibrillation rhythm at the time of inclusion with significant valve disease in cardiogenic shock with reduced kidney function - eGFR < 30 (mL/min/1.73m2); with congenital heart defects with acute pulmonary artery embolism; with isolated left main ostial stenosis; on active oncologic treatment or toxic cardiomyopathy; revascularization by PCI is not possible due to other comorbidities or patient denial of treatment.

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iFR-guided<br>One-stage, virtually planned, iFR-guided and optimized PCI. | Procedure: PCI<br>* Percutaneous coronary intervention with Drug-Eluting Stents<br>|
| Active Comparator: Angiography-guided<br>Standard practice staged angiography-guided PCI | Procedure: PCI<br>* Percutaneous coronary intervention with Drug-Eluting Stents<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCI-related Major adverse cardiac events (MACE) | Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation. | Index admission | 
| PCI-related Major adverse cardiac events (MACE) | Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation. | 3 months | 
| PCI-related Major adverse cardiac events (MACE) | Composite of cardiac death, non-fatal myocardial infarction, unplanned revascularization, stent thrombosis, flow limiting coronary dissections, no-reflow phenomenon, coronary perforations, coronary distal embolization, vascular access site complications requiring blood transfusion or surgical intervention and contrast-induced nephropathy requiring hospitalisation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segmental myocardial deformation by speckle-tracking echocardiography | Change of segmental myocardial deformation | Index admission, 3 months and 12 months | 
| Health-related Quality of Life | Change in health-related quality of life measured using the EQ-5D-5L questionnaire | Index admission, 3 months and 12 months | 
| Number of Participants with Decline of eGFR | Number of participants with decline of eGFR 30% and more in comparison to the first eGFR | Index admission, 3 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iFR, Instantaneous wave free ratio, virtual percutaneous coronary intervention, Acute coronary syndrome, Multivessel