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The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction (HeaRt-V-AMI)

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ClinicalTrials.gov Identifier: NCT05098977
Recruitment Status : Not yet recruiting
First Posted : October 29, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Professor Adrian Covic, 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.

Condition or disease Intervention/treatment
Myocardial Infarction Autonomic Dysfunction Procedure: Heart rate variability measurement Procedure: Percutaneous coronary intervention

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).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack


Intervention Details:
  • 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.
  • Procedure: 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.
    Other Name: PCI


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. All-cause mortality [ Time Frame: in-hospital, 1 month and 1 year ]
    Defined as total number of deaths from any cause

  2. Cardiac mortality [ Time Frame: in-hospital, 1 month and 1 year ]
    Defined as number of deaths due to cardiac causes

  3. Fatal and non-fatal myocardial infarction [ Time Frame: in-hospital, 1 month and 1 year ]
    Defined as a new myocardial infarction

  4. Target vessel revascularization [ Time Frame: 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

  5. Target lesion revascularization [ Time Frame: 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

  6. Stroke [ Time Frame: in-hospital, 1 month and 1 year ]
    Defined as ischemic or hemorrhagic stroke


Other Outcome Measures:
  1. Hospital admissions for heart failure [ Time Frame: 1 year ]
    Defined as any subsequent admission for a primary diagnosis of heart failure

  2. Ventricular arrhythmias [ Time Frame: in-hospital, 1 month and 1 year ]
    Defined as electrocardiographic documentation of ventricular fibrillation or sustained ventricular tachycardia

  3. Left ventricular ejection fraction (LVEF) [ Time Frame: in-hospital, 1 month and 1 year ]
    Appraised using two-dimensional transthoracic echocardiography - Simpsons method

  4. Left ventricular diastolic dysfunction [ Time Frame: in-hospital, 1 month and 1 year ]
    Appraised using two-dimensional transthoracic echocardiography - E/A and E/e prime ratios

  5. Composite of all-cause mortality and major adverse cardiovascular events in special subgroup of patients [ Time Frame: in-hospital, 1 month and 1 year ]
    elderly, diabetes mellitus, chronic kidney disease


Biospecimen Retention:   Samples Without DNA
CK-MB, AST, LDH, cardiac-specific troponin, glycemia, glycosylated hemoglobin, lipid profile, complete blood count, hemoglobin, hematocrit, serum urea and creatinine (estimated glomerular filtration rate using CKD-EPI equation), serum potassium and sodium, sideremia, plasma ferritin, thyroid-stimulating hormone, serum thyroxine, C-reactive protein, N-terminal pro b-type natriuretic peptide.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05098977


Contacts
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Contact: Alexandru Burlacu, MD, PhD +40744488580 alexandru.burlacu@umfiasi.ro
Contact: Crischentian Brinza, MD +40758431764 crischentian.brinza@d.umfiasi.ro

Locations
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Romania
Department of Interventional Cardiology, Institute of Cardiovascular Diseases "Prof. George IM Georgescu" Iasi
Iaşi, Romania, 700503
Contact: Crischentian Brinza, MD    +40758431764    crischentian.brinza@d.umfiasi.ro   
Principal Investigator: Adrian Covic, Professor         
Principal Investigator: Alexandru Burlacu, Professor         
Principal Investigator: Mariana Floria, Professor         
Sponsors and Collaborators
Grigore T. Popa University of Medicine and Pharmacy
Investigators
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Study Chair: Adrian Covic, Professor Gr T Popa University of Medicine and Pharmacy Iasi ROMANIA
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Responsible Party: Professor Adrian Covic, Professor coordinator, Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT05098977    
Other Study ID Numbers: HeaRt-V-AMI
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy:
Heart rate variability
Percutaneous coronary intervention
Drug-eluting stents
Risk assessment
Prognosis
Major adverse cardiovascular events
Left ventricular ejection fraction
Secondary prevention
Additional relevant MeSH terms:
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Autonomic Nervous System Diseases
Primary Dysautonomias
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Nervous System Diseases