Clinical trial NCT05098977: The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: Composite of all-cause mortality and major adverse cardiovascular events (MACE)
timeFrame: in-hospital, 1 month and 1 year
Secondary outcomes:
measure: All-cause mortality
timeFrame: in-hospital, 1 month and 1 year
measure: Cardiac mortality
timeFrame: in-hospital, 1 month and 1 year
measure: Fatal and non-fatal myocardial infarction
timeFrame: in-hospital, 1 month and 1 year
measure: Target vessel revascularization
timeFrame: in-hospital, 1 month and 1 year
measure: Target lesion revascularization
timeFrame: in-hospital, 1 month and 1 year
measure: Stroke
timeFrame: in-hospital, 1 month and 1 year
Other outcomes:
measure: Hospital admissions for heart failure
timeFrame: 1 year
measure: Ventricular arrhythmias
timeFrame: in-hospital, 1 month and 1 year
measure: Left ventricular ejection fraction (LVEF)
timeFrame: in-hospital, 1 month and 1 year
measure: Left ventricular diastolic dysfunction
timeFrame: in-hospital, 1 month and 1 year
measure: Composite of all-cause mortality and major adverse cardiovascular events in special subgroup of patients
timeFrame: in-hospital, 1 month and 1 year
Locations:
city: Iaşi
country: Romania
facility: Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi
Study officials:
affiliation: Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA
name: Adrian Covic, Professor
role: STUDY_CHAIR
References: