Phase II Clinical Trial to Evaluate the Benefits of Postconditioning in ST-Elevation Myocardial Infarction (STEMI)
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate change in heart muscle function from baseline to three months and
      twelve months in participants who present with a heart attack and a completely occluded
      coronary artery. These subjects will be randomized to receive standard Percutaneous
      transluminal coronary angioplasty (PTCA)/Stenting to open the artery or routine PTCA/Stenting
      plus post conditioning. Post conditioning commences immediately upon reperfusion using four
      cycles of thirty second inflations with a standard angioplasty balloon followed by a thirty
      seconds of reperfusion. The investigators hypothesize that Postconditioning reduces the size
      of the heart attack when utilized with successful primary Angioplasty/stent.
    

Detailed description: 
      Single center study involving 140 patients randomized to Post Conditioning + Percutaneous
      coronary intervention (PCI) versus routine PCI during their ST-Elevation Myocardial
      Infarction (STEMI, Heart Attack) presentation. The Post Conditioning protocol consists of
      performing four, 30-second PTCA (Angioplasty) balloon occlusions followed by 30-seconds of
      reperfusion over a total of 4 minutes. The first balloon inflation occurs immediately after
      an angioplasty guidewire is placed through the obstruction in the artery. Following this
      protocol the vessel is stented as part of the usual practice for treatment of STEMI. No other
      treatment differences will occur between the two groups and all patients will receive the
      usual post-STEMI care. Patients in both groups will receive a cardiac MRI 3-5 days following
      their STEMI for measurement of heart attack size and heart muscle function, among other
      measures. Patients will undergo collection of blood for creatine kinase (CK)-MB and troponin
      I every 8 hours for 24 hours following PCI. All patients will be followed by phone follow-up
      visits to review history and major adverse cardiac event (MACE) (death, recurrent STEMI,
      repeat revascularization, arrhythmias, implantable cardioverter-defibrillator (ICD) placement
      and hospitalization for congestive heart failure (CHF)). All patients will be required to
      take P2Y12 inhibitors and aspirin for the duration of the trial. All patients will be treated
      with angiotensin-converting enzyme inhibitor (ACE-I), beta blockers and statins.
    

Intervention name(s): Post Conditioning + Primary PCI; Standard Primary PCI
Intervention type(s): Procedure; Procedure
Intervention description(s): Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.; Routine Percutaneous Coronary Intervention as clinically indicated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myocardial Infarction; STEMI; Post Conditioning; Primary Percutaneous Coronary Intervention