STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

ConditionST Elevation Myocardial Infarction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThomas Engstrom

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

PCI + Ischemic conditioning
Procedure/Surgery
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 ultrasound
Procedure/Surgery
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.

Treatment groups

2,500 Participants

are divided into 4 treatment groups

Group A: PCI standardActive comparator 1 intervention

Group B: PCI standard + ischemic conditioningExperimental treatment 1 intervention

Group C: Stent with ultrasoundExperimental treatment 1 intervention

Group D: Stent without ultrasoundActive comparator 1 intervention

Trial 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

Time frame