STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

Study Overview
=================
Brief Summary
-----------------
The purpose of is study is to investigate whether ischemic postconditioning (iPOST) and intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.

Official Title
-----------------
The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)

Conditions
-----------------
ST Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: PCI + Ischemic conditioning
* Procedure: Stent with ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Acute onset of chest pain with <12 hours duration STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI. Exclusion Criteria (iPOST2): Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI > 12 hours Culprit in bypass graft Other reason for not including the patient Exclusion Criteria (iSTEMI): Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI > 12 hours Culprit in bypass graft Other reason

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: Factorial Assignment
Interventional Model Description: 2x2 factorial As a second randomization to the iPOST2 trial (ID: H-180512561,NCT03787745) patients are randomized 1:1 to either a) receiving ultrasound guidance before and after stent placement or b) no ultrasound, independently of randomization in the iPOST2 trial. The iPOST2 trial was initiated February 2019.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCI standard<br> | Procedure: PCI + Ischemic conditioning<br>* IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.<br>|
| Experimental: PCI standard + ischemic conditioning<br> | Procedure: PCI + Ischemic conditioning<br>* IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.<br>|
| Experimental: Stent with ultrasound<br> | Procedure: Stent with ultrasound<br>* IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.<br>|
| Active Comparator: Stent without ultrasound<br> | Procedure: Stent with ultrasound<br>* IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iPOST | Number of participants that experience all-cause mortality or hospitalization for heart failure | Until expected number of events are adjudicated up til 3 years | 
| iSTEMI (IVUS) | Number of participants that experience all-cause mortality, unplanned ischemia-driven revascularization and new myocardial infarction | Until expected number of events are adjudicated up til 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iSTEMI (IVUS) | Target vessel failure (cardiac mortality, unplanned ischemia driven target vessel revascularization or target vessel myocardial infarction | Until expected number of events are adjudicated 3 years | 
| iSTEMI (IVUS) | Individual components of the primary endpoint | Until expected number of events are adjudicated 3 years | 
| iSTEMI (IVUS) | Cardiac mortality | Until expected number of events are adjudicated 3 years | 
| iSTEMI (IVUS) | Unplanned ischemia driven target vessel revascularization | Until expected number of events are adjudicated 3 years | 
| iSTEMI (IVUS) | Unplanned ischemia driven target vessel myocardial infarction | Until expected number of events are adjudicated 3 years | 
| iSTEMI (IVUS) | Unplanned ischemia driven target lesion revascularization | Until expected number of events are adjudicated 3 years | 
| iSTEMI (IVUS) | Definite/probable stent-thrombosis | Until expected number of events are adjudicated 3 years | 
| iPOST | Individual components of the primary endpoint | Until expected number of events are adjudicated 3 years | 
| iPOST | Cardiac mortality | Until expected number of events are adjudicated 3 years | 
| iPOST | Ischemia driven target vessel revascularization | Until expected number of events are adjudicated 3 years | 
| iPOST | New myocardial infarction | Until expected number of events are adjudicated 3 years | 
| iPOST | Quality of life | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary PCI, Coronary angiography, Intravascular ultra sound (IVUS)