NCT05098977

The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Grigore T. Popa University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Myocardial Infarction
• Autonomic Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Heart rate variability measurement	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.
PROCEDURE	Percutaneous coronary intervention	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2021-10-29
• Last updated: 2021-11-05

Locations

1 site across 1 country: Romania