RecruitingNot ApplicableNCT03787745

Ischemic Postconditioning in STEMI Patients Treated With Primary PCI

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


Sponsor

Rigshospitalet, Denmark

Enrollment

1,800 participants

Start Date

Feb 4, 2019

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

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

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Interventions

PROCEDUREIschemic postconditioning

After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed

PROCEDUREConventional

State of the art primary PCI, however thrombectomy is not allowed


Locations(1)

The Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

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NCT03787745


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