iSTEMI: Intravascular Ultrasound Guided PCI in STEMI

Sponsor

Thomas Engstrom (Other)

Overall Status

Recruiting

CT.gov ID

NCT04775914

Collaborator

(none)

2,500

Enrollment

Location

Arms

118

Anticipated Duration (Months)

21.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of is study is to investigate whether intravascular ultrasound-guided (IVUS) percutaneous coronary intervention (PCI) improve the clinical outcome of patients with ST-segment elevation myocardial infarction treated with primary PCI.

Condition or Disease	Intervention/Treatment	Phase
ST Elevation Myocardial Infarction	Procedure: PCI + Ischemic conditioning Procedure: Stent with ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention 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 2019.2x2 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)

Primary Purpose:

Treatment

Official Title:

The STEMI Optimization Trial - Intravascular Ultrasound Guided PCI in STEMI

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Feb 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PCI standard	Procedure: PCI + Ischemic conditioning 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.
Experimental: PCI standard + ischemic conditioning	Procedure: PCI + Ischemic conditioning 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.
Experimental: Stent with ultrasound	Procedure: Stent with ultrasound 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.
Active Comparator: Stent without ultrasound	Procedure: Stent with ultrasound 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.

Outcome Measures

Primary Outcome Measures

iPOST [Until expected number of events are adjudicated up til 3 years]
Number of participants that experience all-cause mortality or hospitalization for heart failure
IVUS [Until expected number of events are adjudicated up til 3 years]
Number of participants that experience all-cause mortality, target vessel revascularization and new myocardial infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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