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

Study Overview
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Brief Summary
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This study focuses on Cardioprotective strategies.

Official Title
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A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment

Conditions
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ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Other: Conventional primary PCI
* Other: Ischemic postconditioning.
* Other: Deferred stenting in primary PCI.


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment.<br>Conventional primary PCI in STEMI. | Other: Conventional primary PCI<br>* Conventional primary PCI in STEMI with implantation of DES.<br>* Other names: pPCI;|
| Experimental: IPost<br>Ischemic postconditioning in STEMI. | Other: Ischemic postconditioning.<br>* 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.<br>* Other names: Mechanical postconditioning;|
| Experimental: Deferred primary PCI.<br>Deferred strategy in STEMI. | Other: Deferred stenting in primary PCI.<br>* In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.<br>* Other names: Deferred stenting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, heart failure (postconditioning) |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Ischemic postconditioning, Deferred stenting, Primary PCI