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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Autonomic Dysfunction
• Intervention / Treatment: Procedure: Heart rate variability measurement; Procedure: Percutaneous coronary intervention

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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Alexandru Burlacu, MD, PhD; Phone Number: +40744488580; Email: alexandru.burlacu@umfiasi.ro
• Study Contact Backup: Name: Crischentian Brinza, MD; Phone Number: +40758431764; Email: crischentian.brinza@d.umfiasi.ro

Study Locations

• Romania
  • Iaşi, Romania, 700503
    • Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi
    • Contact: Crischentian Brinza, MD; Phone Number: +40758431764; Email: crischentian.brinza@d.umfiasi.ro
    • Principal Investigator: Adrian Covic, Professor
    • Principal Investigator: Alexandru Burlacu, Professor
    • Principal Investigator: Mariana Floria, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with STEMI referred to catheterization laboratory from Institute of Cardiovascular Diseases "Prof. George IM Georgescu", Iasi, within 12 hours from symptoms onset.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of all-cause mortality and major adverse cardiovascular events (MACE)	MACE will be defined as cardiac mortality, fatal and non-fatal myocardial infarction, unplanned target vessel revascularization and stroke)	in-hospital, 1 month and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Defined as total number of deaths from any cause	in-hospital, 1 month and 1 year
Cardiac mortality	Defined as number of deaths due to cardiac causes	in-hospital, 1 month and 1 year
Fatal and non-fatal myocardial infarction	Defined as a new myocardial infarction	in-hospital, 1 month and 1 year
Target vessel revascularization	Defined as unplanned PCI or coronary artery bypass graft surgery for a stenosis in another part of the vessel treated at the index PCI	in-hospital, 1 month and 1 year
Target lesion revascularization	Defined as repeat PCI or coronary artery bypass graft surgery of the target lesion treated at the index PCI	in-hospital, 1 month and 1 year
Stroke	Defined as ischemic or hemorrhagic stroke	in-hospital, 1 month and 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admissions for heart failure	Defined as any subsequent admission for a primary diagnosis of heart failure	1 year
Ventricular arrhythmias	Defined as electrocardiographic documentation of ventricular fibrillation or sustained ventricular tachycardia	in-hospital, 1 month and 1 year
Left ventricular ejection fraction (LVEF)	Appraised using two-dimensional transthoracic echocardiography - Simpsons method	in-hospital, 1 month and 1 year
Left ventricular diastolic dysfunction	Appraised using two-dimensional transthoracic echocardiography - E/A and E/e prime ratios	in-hospital, 1 month and 1 year
Composite of all-cause mortality and major adverse cardiovascular events in special subgroup of patients	elderly, diabetes mellitus, chronic kidney disease	in-hospital, 1 month and 1 year

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy
• Investigators: Study Chair: Adrian Covic, Professor, Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Prognosis; Percutaneous coronary intervention; Secondary prevention; Heart rate variability; Risk assessment; Left ventricular ejection fraction; Major adverse cardiovascular events; Drug-eluting stents
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Myocardial Infarction; Infarction; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: HeaRt-V-AMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No