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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Composite of all-cause mortality and major adverse cardiovascular events (MACE)
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
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).
Investigators
Professor Adrian Covic
Professor coordinator
Grigore T. Popa University of Medicine and Pharmacy
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.
Outcomes
Primary Outcomes
Composite of all-cause mortality and major adverse cardiovascular events (MACE)
Time Frame: 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 Outcomes
- Target vessel revascularization(in-hospital, 1 month and 1 year)
- Stroke(in-hospital, 1 month and 1 year)
- Cardiac mortality(in-hospital, 1 month and 1 year)
- Fatal and non-fatal myocardial infarction(in-hospital, 1 month and 1 year)
- All-cause mortality(in-hospital, 1 month and 1 year)
- Target lesion revascularization(in-hospital, 1 month and 1 year)