STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

Thomas Engstrom2,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,500

Conditions

ST Elevation Myocardial Infarction

Interventions

PCI + Ischemic conditioningPROCEDURE

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.

Stent with ultrasoundPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Heart Center, Rigshospitalet

Copenhagen, Capital Region, Denmark

RECRUITING

Outcomes

Primary Outcomes

iPOST

Number of participants that experience all-cause mortality or hospitalization for heart failure

Time frame: 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

Time frame: Until expected number of events are adjudicated up til 3 years

Secondary Outcomes

iSTEMI (IVUS)

Target vessel failure (cardiac mortality, unplanned ischemia driven target vessel revascularization or target vessel myocardial infarction