Clinical trial NCT04775914: STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance
Official title: The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: Primary PCI
Coronary angiography
Intravascular ultra sound (IVUS)
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: iPOST
timeFrame: Until expected number of events are adjudicated up til 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated up til 3 years
Secondary outcomes:
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: 1 year
Other outcomes:
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: Until expected number of events are adjudicated 3 years
measure: iSTEMI (IVUS)
timeFrame: 1 year
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
measure: iPOST
timeFrame: Until expected number of events are adjudicated 3 years
Locations:
city: Copenhagen
country: Denmark
facility: Heart Center, Rigshospitalet
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas Engstrøm, MD PhD DMSci
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Jacob Lønborg, MD PhD DMSci
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Francis Joshi, Md, PhD
role: STUDY_CHAIR
References: