Analysis of the Efficacy of Cardiac Ischemic Postconditioning With New Clinical End-points Using Novel Biomarkers
Condition: Acute Myocardial Infarction With ST Elevation
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The aim of the present study was to investigate the efficacy of ischemic postconditioning in
      acute myocardial infarction patients. The safety of patients enrolled in the study was
      ensured during the entire study. Over 18 years old men and women were enrolled in the study
      who arrived to 2 of the most acknowledged Hungarian cardiac centres due to acute myocardial
      infarction and fulfilled all inclusion and exclusion criteria as per protocol. Patients in
      the order of their arrival were assigned either to control or post conditioned groups by
      turns. Medical treatment of the control group was done according to standard Percutaneous
      Coronary Intervention (PCI) guidelines, i.e. there was no further intervention after artery
      opening for 8 minutes, then stenting was performed. In the post conditioned group, after
      reperfusion has been confirmed, the coronary artery was occluded by inflation of the stent
      balloon 4 times (for 1-1 minute) followed by 1-1-minute reperfusion repeatedly to induce
      ischemic postconditioning. Postconditioning procedure was followed by stenting as in the
      control group. All other interventions and treatments in both patient groups were identical
      according to guidelines.
    

Detailed description: 
      Over 18 years old men and women were enrolled in the study who arrived to 2 of the most
      acknowledged Hungarian cardiac centres due to acute myocardial infarction and fulfilled all
      inclusion and exclusion criteria as per protocol. Patients in the order of their arrival were
      assigned either to control or post conditioned groups by turns. After closing patient
      enrolment, further subgrouping will be performed in case sufficient group size has been
      achieved as follows: (1) normal, control, (2) normal, post conditioned, (3)
      hypercholesterolemic, not treated with statins, control, (4) hypercholesterolemic, not
      treated with statins, post conditioned, (5) statin treated, control, (6) statin treated, post
      conditioned.

      Characterisation of postconditioning is performed by the following parameters:

        1. Blood tests 5 minutes before as well as 8, 60 minutes, 24 hours, and 3 months after PCI
           to measure nitrotyrosine, a biomarker of peroxynitrite formation (nitrosative stress) by
           ELISA; B-type natriuretic peptide, a biomarker of heart failure by ELISA; matrix
           metalloproteinase activities (MMP-2 and MMP-9) putative biomarkers of cardiac
           remodelling by zymography; microRNA expression pattern by sequencing and its validation
           by quantitative real-time polymerase chain reaction (PCR).

        2. Routine laboratory tests 6, 12 and 48 hours after PCI including creatine kinase (CKMB)
           and cardiac troponin T (cTnT).

        3. ECG immediately after recanalization and intervention after 60 and 90 minutes, then 12,
           24, 36 and 48 hours later 12-lead ECG is registered.

        4. Echocardiography: 48 hours after intervention, standard view to judge left ventricle
           segments movement disorders

        5. Angiography: Blush, Syntax score, and ischemic risk zone (area at risk, AAR) are
           determined

        6. cardiac late enhancement magnetic resonance (MR) imaging to determine infarct size

      At 3-month follow-up visit the following parameters were measured: echocardiography for
      restitution assessment, cardiac late enhancement MR imaging to determine infarct size and
      cardiac function, blood sampling for above mentioned biochemical laboratory tests
    

Intervention name(s): Postconditioning; Percutaneous coronary intervention
Intervention type(s): Procedure; Device
Intervention description(s): The protocol of primary PCI followed by stenting is executed according to the descriptions according to the majority of relevant scientific literature on postconditioning studies and in accordance with the most recent guidelines. In the post conditioned group, after recanalization, the artery is occluded by inflation of stent balloon (4 times for 1-1 minute) followed by 1-1-minute reperfusion, repeatedly. Eight minutes after the start of examination, angiography is made in order to determine blood flow. Intervention is finished by the operator and another angiographic image is made (identical to initial standard projection).; Percutaneous coronary intervention as per European Society of Cardiology guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ischemic postconditioning; acute myocardial infarction; Investigator Initiated Trial; biomarker; coronary artery disease; ischemic; postconditioning; infarction; infarct size; area at risk; coronary occlusion; balloon catheter; percutaneous coronary intervention; PCI; MRI