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

Not yet recruiting

• Conditions: Myocardial Infarction; Autonomic Dysfunction

• Registration Number: NCT05098977
• Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy

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).

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study Start: 2021-11
• Last Update Posted: 2021-11-05
• Primary Completion: 2023-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi; 🇷🇴 Iaşi, Romania