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| Name | Class |
|---|---|
| Semmelweis University Heart and Vascular Center | OTHER |
| Szeged University | OTHER |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postconditioning | Experimental | Patients that underwent postconditioning after primary percutaneous coronary intervention. |
|
| control | Other | Patients that underwent primary percutaneous coronary intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postconditioning | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac magnetic resonance imaging | Left and right ventricular function, myocardial scar, transmurality, diffusion spectrum imaging (DSI) measurement and evaluation | 3 months after acute myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiography measurement of Cardiac Ejection Fraction | Measurement of Cardiac Ejection Fraction using Teicholz and Simpson methods on both study arms. | 48 hours and 3 months after acute myocardial infarction |
| Echocardiography measurement of cardiac left ventricular segments for wall motion abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Béla Merkely, MD, PhD | Heart and Vascular Center, Semmelweis University, Budapest | Principal Investigator |
| Peter Ferdinandy, MD, PhD, MBA | Pharmahungary Group | Study Director |
| Imre Ungi, MD, PhD | University of Szeged, Faculty of Medicine, Cardiology Center, Department of Invasive Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Vascular Center, Semmelweis University | Budapest | H-1122 | Hungary | |||
| Pharmahungary Group |
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| Label | URL |
|---|---|
| Website of Pharmahungary Group. | View source |
| Website of Semmelweis University Heart and Vascular Center. | View source |
| Website of Department of Invasive Cardiology of Cardiology Center, Faculty of Medicine, University of Szeged. |
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|
| Percutaneous coronary intervention | Device | Percutaneous coronary intervention as per European Society of Cardiology guidelines. |
|
Calculation of cardiac wall motion score index on both study arms. |
| 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. | 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. | 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. | 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. | 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. | 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. | Post-procedure 60, 90 minutes, and 12, 24, 48 hours. |
| Szeged |
| 6722 |
| Hungary |
| Department of Invasive Cardiology of Cardiology Center, Faculty of Medicine, University of Szeged | Szeged | H-6720 | Hungary |
| View source |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D007511 | Ischemia |
| D007238 | Infarction |
| D054059 | Coronary Occlusion |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D057775 | Ischemic Postconditioning |
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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