The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction — HeaRt-V-AMI  

Myocardial Infarction Clinical Trial

Official title: The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction: From Primary Angioplasty to Secondary Long-term Prevention - a Single Centre, Prospective, Observational Cohort Study

Status Not yet recruiting

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). ;

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Infarction
• Myocardial Infarction
• Primary Dysautonomias

• 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
• Start date: November 2021
• Completion date: October 2024