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

Myocardial Infarction Clinical Trial

— HeaRt-V-AMI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05098977
• Other study ID #: HeaRt-V-AMI
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: October 2024

Study information

• Verified date: October 2021
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: Alexandru Burlacu, MD, PhD
• Phone: +40744488580
• Email: alexandru.burlacu[@]umfiasi.ro
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Infarction
• Myocardial Infarction
• Primary Dysautonomias

Intervention

Procedure:
• Heart rate variability measurement
HRV will be measured at the moment of patients' admission to the cardiac catheterization laboratory on the top of therapy guided by European guidelines. Both, time- and frequency-domain parameters (respectively, SDNN, SDANN, RMSSD and LF, HF, LF/HF ratio) of the HRV will be obtained using a validated medical device during 5-minute segments before and after revascularization of the culprit artery. In addition, HRV will be evaluated in ambulatory setting, at 1 month and at 6 months after the index event. Obtained interbeat interval data will be further analysed using a dedicated software in order to derive specified HRV parameters.
• Percutaneous coronary intervention
Coronary angiography and PCI will be performed using femoral or radial approach after local anesthetic infiltration with Lidocaine and arterial sheath placement. Following the culprit lesion detection and guidewire placement, thromboaspiration and glycoprotein IIb/IIIa inhibitors will be left to the operator decision. Also, the choice of coronary stenting technique and stent sizing will be performed according to the operator experience. Antiplatelet and anticoagulant drugs will be administered in concordance with latest European guidelines.

Locations

Country	Name	City	State
Romania	Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

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