Myocardial Infarction Clinical Trial
— HeaRt-V-AMIOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | October 2024 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Romania | Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi | Iasi |
Lead Sponsor | Collaborator |
---|---|
Grigore T. Popa University of Medicine and Pharmacy |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital admissions for heart failure | Defined as any subsequent admission for a primary diagnosis of heart failure | 1 year | |
Other | Ventricular arrhythmias | Defined as electrocardiographic documentation of ventricular fibrillation or sustained ventricular tachycardia | in-hospital, 1 month and 1 year | |
Other | Left ventricular ejection fraction (LVEF) | Appraised using two-dimensional transthoracic echocardiography - Simpsons method | in-hospital, 1 month and 1 year | |
Other | Left ventricular diastolic dysfunction | Appraised using two-dimensional transthoracic echocardiography - E/A and E/e prime ratios | in-hospital, 1 month and 1 year | |
Other | 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 | |
Primary | 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 | All-cause mortality | Defined as total number of deaths from any cause | in-hospital, 1 month and 1 year | |
Secondary | Cardiac mortality | Defined as number of deaths due to cardiac causes | in-hospital, 1 month and 1 year | |
Secondary | Fatal and non-fatal myocardial infarction | Defined as a new myocardial infarction | in-hospital, 1 month and 1 year | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Stroke | Defined as ischemic or hemorrhagic stroke | in-hospital, 1 month and 1 year |
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