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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
100
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.
Heart and Vascular Center, Semmelweis University
Budapest, Hungary
Pharmahungary Group
Szeged, Hungary
Department of Invasive Cardiology of Cardiology Center, Faculty of Medicine, University of Szeged
Szeged, Hungary
Cardiac magnetic resonance imaging
Left and right ventricular function, myocardial scar, transmurality, diffusion spectrum imaging (DSI) measurement and evaluation
Time frame: 3 months after acute myocardial infarction
Echocardiography measurement of Cardiac Ejection Fraction
Measurement of Cardiac Ejection Fraction using Teicholz and Simpson methods on both study arms.
Time frame: 48 hours and 3 months after acute myocardial infarction
Echocardiography measurement of cardiac left ventricular segments for wall motion abnormalities
Calculation of cardiac wall motion score index on both study arms.
Time frame: 48 hours and 3 months after acute myocardial infarction
Laboratory measurement of blood Nitrotyrosine levels.
Laboratory measurement of Nitrotyrosine levels in blood samples with ELISA on both study arms.
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Laboratory measurement of blood MMP activity.
Laboratory measurement of MMP activity in blood samples with zymography on both study arms.
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Laboratory characterization of microRNA patterns with microRNA array
Laboratory characterization of microRNA expression pattern in blood samples with with microRNA array on both study arms.
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Validation of selected microRNA with quantitative real-time PCR
Out of the differentially expressed microRNAs identified in Outcome 6, up to 10 different miRNAs will be selected for further validation of their specific expression change (expressed by fold-change) by quantitative real-time PCR in up to 10 randomly selected patients on both study arms, respectively.
Time frame: 5 minutes before PCI as well as 8 minutes after, 60 minutes, 6, 12, 24, 48 hours, and 3 months after acute myocardial infarction
Electrocardiography ST segment post-procedure evaluation
Distortion in ST segment amplitude in millivolt (mV) and duration measured in milliseconds (ms) after procedure measured by 12-lead Electrocardiography (ECG) will be evaluated on both study arms.
Time frame: Post-procedure 60, 90 minutes, and 12, 24, 48 hours.
Electrocardiography T wave post-procedure evaluation
Distortion in T wave amplitude in millivolt (mV) and duration measured in milliseconds (ms) after procedure measured by 12-lead Electrocardiography (ECG) will be evaluated on both study arms.
Time frame: Post-procedure 60, 90 minutes, and 12, 24, 48 hours.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.