STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Procedure: PCI + Ischemic conditioning; Procedure: Stent with ultrasound

• Registration Number: NCT04775914
• Lead Sponsor: Thomas Engstrom

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Study Start: 2021-04-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-19
• Primary Completion: 2027-02-01
• Study Completion: 2031-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PCI standard	PCI + Ischemic conditioning	-
PCI standard + ischemic conditioning	PCI + Ischemic conditioning	-
Stent with ultrasound	Stent with ultrasound	-
Stent without ultrasound	Stent with ultrasound	-

Primary Outcome Measures

Name	Time	Method
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
iSTEMI (IVUS)	Until expected number of events are adjudicated up til 3 years	Number of participants that experience all-cause mortality, unplanned ischemia-driven revascularization and new myocardial infarction

Secondary Outcome Measures

Name	Time	Method
iPOST	1 year	Quality of life
iSTEMI (IVUS)	Until expected number of events are adjudicated 3 years	Definite/probable stent-thrombosis

Trial Locations

Locations (1)

Heart Center, Rigshospitalet; 🇩🇰 Copenhagen, Capital Region, Denmark