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Aims
The following data will be collected:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate variability measurement | Procedure | HRV will be measured at the moment of patients' admission to the cardiac catheterization laboratory on the top of therapy guided by European guidelines. Both, time- and frequency-domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio) of the HRV will be obtained using a validated medical device during 5-minute segments before and after revascularization of the culprit artery. In addition, HRV will be evaluated in ambulatory setting, at 1 month and at 6 months after the index event. Obtained interbeat interval data will be further analysed using a dedicated software in order to derive specified HRV parameters. | ||
| Percutaneous coronary intervention | Procedure | Coronary angiography and PCI will be performed using femoral or radial approach after local anesthetic infiltration with Lidocaine and arterial sheath placement. Following the culprit lesion detection and guidewire placement, thromboaspiration and glycoprotein IIb/IIIa inhibitors will be left to the operator decision. Also, the choice of coronary stenting technique and stent sizing will be performed according to the operator experience. Antiplatelet and anticoagulant drugs will be administered in concordance with latest European guidelines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality and major adverse cardiovascular events (MACE) | MACE will be defined as cardiac mortality, fatal and non-fatal myocardial infarction, unplanned target vessel revascularization and stroke) | in-hospital, 1 month and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Defined as total number of deaths from any cause | in-hospital, 1 month and 1 year |
| Cardiac mortality | Defined as number of deaths due to cardiac causes |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital admissions for heart failure | Defined as any subsequent admission for a primary diagnosis of heart failure | 1 year |
| Ventricular arrhythmias | Defined as electrocardiographic documentation of ventricular fibrillation or sustained ventricular tachycardia |
Inclusion Criteria:
Exclusion Criteria:
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Patients with STEMI referred to catheterization laboratory from Institute of Cardiovascular Diseases "Prof. George IM Georgescu", Iasi, within 12 hours from symptoms onset.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandru Burlacu, MD, PhD | Contact | +40744488580 | alexandru.burlacu@umfiasi.ro | |
| Crischentian Brinza, MD | Contact | +40758431764 | crischentian.brinza@d.umfiasi.ro |
| Name | Affiliation | Role |
|---|---|---|
| Adrian Covic, Professor | Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi | Iași | 700503 | Romania |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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CK-MB, AST, LDH, cardiac-specific troponin, glycemia, glycosylated hemoglobin, lipid profile, complete blood count, hemoglobin, hematocrit, serum urea and creatinine (estimated glomerular filtration rate using CKD-EPI equation), serum potassium and sodium, sideremia, plasma ferritin, thyroid-stimulating hormone, serum thyroxine, C-reactive protein, N-terminal pro b-type natriuretic peptide.
| in-hospital, 1 month and 1 year |
| Fatal and non-fatal myocardial infarction | Defined as a new myocardial infarction | in-hospital, 1 month and 1 year |
| Target vessel revascularization | Defined as unplanned PCI or coronary artery bypass graft surgery for a stenosis in another part of the vessel treated at the index PCI | in-hospital, 1 month and 1 year |
| Target lesion revascularization | Defined as repeat PCI or coronary artery bypass graft surgery of the target lesion treated at the index PCI | in-hospital, 1 month and 1 year |
| Stroke | Defined as ischemic or hemorrhagic stroke | in-hospital, 1 month and 1 year |
| in-hospital, 1 month and 1 year |
| Left ventricular ejection fraction (LVEF) | Appraised using two-dimensional transthoracic echocardiography - Simpsons method | in-hospital, 1 month and 1 year |
| Left ventricular diastolic dysfunction | Appraised using two-dimensional transthoracic echocardiography - E/A and E/e prime ratios | in-hospital, 1 month and 1 year |
| Composite of all-cause mortality and major adverse cardiovascular events in special subgroup of patients | elderly, diabetes mellitus, chronic kidney disease | in-hospital, 1 month and 1 year |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019060 | Minimally Invasive Surgical Procedures |