DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction

Overview

This study focuses on Cardioprotective strategies.

Full Title of Study: “A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2016

Interventions

  • Other: Conventional primary PCI
    • Conventional primary PCI in STEMI with implantation of DES.
  • Other: Ischemic postconditioning.
    • Primary PCI in STEMI with implantation of DES. Following re-opening of the culprit artery mechanical postconditioning with 4 cycles of 30/30 sec. reperfusion/re-occlusion i performed.
  • Other: Deferred stenting in primary PCI.
    • In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.

Arms, Groups and Cohorts

  • Active Comparator: Conventional treatment.
    • Conventional primary PCI in STEMI.
  • Experimental: IPost
    • Ischemic postconditioning in STEMI.
  • Experimental: Deferred primary PCI.
    • Deferred strategy in STEMI.

Clinical Trial Outcome Measures

Primary Measures

  • All cause mortality, heart failure (postconditioning)
    • Time Frame: 2 years

Secondary Measures

  • Infarct size in relation to area at risk as determined by MRI after 3 month
    • Time Frame: 3 month
    • Infarct size Salvage index
  • All cause mortality, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year (deferred stent strategy)
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years.
  • Acute onset of chest pain of < 12 hours' duration.
  • ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.

Culprit lesion in a major native vessel.

Exclusion Criteria

  • Pregnancy.
  • Known intolerance of ASA, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thomas Engstrom, MD, DMSci, PhD – Rigshospitalet, Denmark
  • Overall Official(s)
    • Lars Koeber, Prof., DMSci, Principal Investigator, The Heart Center, Rigshospitalet, University of Copenhagen
    • Thomas Engstrom, MD, DMSci, Principal Investigator, The Heart Center, Rigshospitalet, University of Copenhagen
    • Henning Kelbaek, MD, DMSci, Principal Investigator, The Heart Center, Rigshospitalet, University of Copenhagen

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