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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Study Primary Completion Date: February 2016
- 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
- All cause mortality, heart failure (postconditioning)
- Time Frame: 2 years
- 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
- 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.
- 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
- 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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