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Clinical Trial Summary

Aims - heart rate variability (HRV) assessment in patients with acute myocardial infarction who undergo primary percutaneous coronary intervention (PCI); - measurement of HRV using a device approved for medical use in Europe; - assessment of the correlation between HRV and short- and long-term adverse cardiovascular events (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease) in patients treated by primary PCI for acute myocardial infarction; - creating a registry of HRV parameters measured in a contemporary cohort of patients with acute myocardial infarction.


Clinical Trial Description

The following data will be collected: - general demographic data; - time from chest pain onset to primary PCI; - comorbidities (ischemic heart disease, arterial hypertension, previous PCI or coronary artery bypass surgery - CABG, heart failure, peripheral artery disease, atrial fibrillation, stroke, diabetes mellitus, kidney disease); - cardiovascular risk factors (age, body mass index, smoking, abdominal perimeter, sedentarism, gender, inflammation); - cardiac rhythm derived from electrocardiographic data; - HRV time- and frequency domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio); - routine biological data and biomarkers, including creatine kinase-MB (CK-MB), aspartate transaminase (AST), lactate dehydrogenase (LDH) and cardiac-specific troponin; - left ventricular ejection fraction at admission, at discharge and at follow-up (1 month, 6 months and 1 year); - initial and final thrombolysis in myocardial infarction (TIMI) flow; - type of stent used for coronary angioplasty; - Global Registry of Acute Coronary Events (GRACE) score; - SYNTAX score II in case of three-vessel coronary disease or involving left main stem; - in-hospital, one month and long-term clinical outcomes (composite of all-cause mortality and major adverse cardiovascular events - MACE; ventricular arrhythmias; hospital admissions for heart failure; left ventricular systolic and diastolic disfunction; MACE in special subgroups of patients - elderly, diabetes mellitus, chronic kidney disease). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05098977
Study type Observational
Source Grigore T. Popa University of Medicine and Pharmacy
Contact Alexandru Burlacu, MD, PhD
Phone +40744488580
Email alexandru.burlacu@umfiasi.ro
Status Not yet recruiting
Phase
Start date November 2021
Completion date October 2024

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