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

Grigore T. Popa University of Medicine and Pharmacy

Status: Not yet enrolling

Conditions: Myocardial Infarction; Autonomic Dysfunction

Treatments: Procedure: Percutaneous coronary intervention; Procedure: Heart rate variability measurement

Study type: Observational

Funder types: Other

Identifiers

NCT05098977

HeaRt-V-AMI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with ST-Elevation Myocardial Infarction (STEMI) treated with primary PCI within 12 hours from symptoms onset;
• patients in sinus rhythm;
• patients who have read and signed the standard informed consent regarding enrolment in the study.

Exclusion criteria

• unconscious or intubated patients who are unable to sign the standard informed consent;
• patients with atrial fibrillation;
• patients with sinus node dysfunction or atrioventricular block of any degree;
• frequent premature supraventricular or ventricular contractions;
• paced ventricular rhythm;
• patients treated with positive inotropic and chronotropic drugs;
• history of myocardial infarction or myocardial revascularization (PCI or CABG);
• patients refusal.