The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)

Official Summary

In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 1,800 participants

Interventions

• PROCEDURE: Ischemic postconditioning — After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed
• PROCEDURE: Conventional — State of the art primary PCI, however thrombectomy is not allowed

Primary Outcomes

• All cause mortality or hospitalization for heart failure (From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)

Secondary Outcomes

• All cause mortality (From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months)
• Percentage of patients hospitalized for heart failure (From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months)
• Percentage of patients with myocardial infarction (From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
• Cardiovascular death (From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)
• Percentage of patients with stroke (From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months)

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.
* TIMI flow 0-1 in infarct related artery

Exclusion Criteria:

* Potential pregnancy
* Refusal to participate
* OHCA without subsequent consciousness despite ROSC
* Thrombectomy considered unavoidable

Trial Locations

• The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

More ST Segment Elevation Myocardial Infarction Trials

View all ST Segment Elevation Myocardial Infarction clinical trials