STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance

NCT04775914 | Recruiting

• 1 other identifier: H-18051256b
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction

Keywords

Primary PCI; Coronary angiography; Intravascular ultra sound (IVUS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

Other Outcomes (9)

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

• iSTEMI (IVUS)

  Until expected number of events are adjudicated 3 years

Study Arms (4)

PCI standard

ACTIVE COMPARATOR

Procedure: PCI + Ischemic conditioning

PCI standard + ischemic conditioning

EXPERIMENTAL

Procedure: PCI + Ischemic conditioning

Stent with ultrasound

EXPERIMENTAL

Procedure: Stent with ultrasound

Stent without ultrasound

ACTIVE COMPARATOR

Procedure: Stent with ultrasound

Interventions

PCI + Ischemic conditioning PROCEDURE

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.

PCI standard; PCI standard + ischemic conditioning

Stent with ultrasound PROCEDURE

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.

Stent with ultrasound; Stent without ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Thomas Engstrom: lead

Study Sites (1)

Heart Center, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Stents; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Thomas Engstrøm, MD PhD DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

• Jacob Lønborg, MD PhD DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

• Francis Joshi, Md, PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Thomas Engstrøm, MD PhD DSci

CONTACT

+45 3545 8444; Thomas.Engstroem@regionh.dk

Jacob Lønborg, MD PhD DMSci

CONTACT

+45 3545 8176; jacob.thomsen.loenborg01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 1, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2031
• Last Updated: March 30, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)