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

NCT ID: NCT05098977

Last Updated: 2021-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2024-10-31

Brief 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

Keywords

Heart rate variability; Percutaneous coronary intervention; Drug-eluting stents; Risk assessment; Prognosis; Major adverse cardiovascular events; Left ventricular ejection fraction; Secondary prevention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

PCI

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grigore T. Popa University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Professor Adrian Covic

Professor coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Covic, Professor

Role: STUDY_CHAIR

Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA

Locations

Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi

Iași, , Romania

Countries

Romania

Central Contacts

Alexandru Burlacu, MD, PhD

Role: CONTACT

Phone: +40744488580

Email: alexandru.burlacu@umfiasi.ro

Crischentian Brinza, MD

Role: CONTACT

Phone: +40758431764

Email: crischentian.brinza@d.umfiasi.ro

Facility Contacts

Crischentian Brinza, MD

Role: primary

Other Identifiers

HeaRt-V-AMI

Identifier Type: -

Identifier Source: org_study_id