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Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction (EARLY-VAGUS)

Primary Purpose

Myocardial Infarction, Tachyarrhythmia

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Parasym device (active, current (mA) < discomfort threshold)
Parasym device (sham, current (mA) = 0)
Sponsored by
Hippocration General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring transcutaneous vagal nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients aged ≥18 years ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule Exclusion Criteria: A patient will be excluded from the study if one or more of all the following criteria are present: < 3 months after prior ablation Patients on amiodarone Patients with known thyroid issues, on renal-dialysis Life expectancy of < 12 months Complex congenital heart disease Cardiogenic shock Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker Complete heart block or trifascicular block without an implantable pacemaker Recurrent vasovagal syncope Pre-existing implantable cardioverter-defibrillator (ICD) Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded)) On the heart transplant list Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications) Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)

Sites / Locations

  • Heart Rhythm Institute, University of Oklahoma Health Sciences Center
  • First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens
  • Athens Heart Center Amarousion
  • Biomedical Engineering, Khalifa University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Transcutaneous Vagal Nerve Stimulation

Sham Transcutaneous Vagal Nerve Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Change of Ventricular tachycardia burden
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate their number of Premature ventricular contractions (PVCs) and number of Non-Sustain Ventricular Tachycardias (NSVT).

Secondary Outcome Measures

Change of Heart Rate Variability
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Variability
Change of Heart Rate Turbulence
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Turbulence
Change of Deceleration Capacity (DC)
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Deceleration Capacity
Change of Echocardiographic strain
Patients will undergo echocardiography at 1, 7 and 40 days to assess Myocardial substrate lesions and Post-infraction fibrosis
Change of Left Ventricle Ejection Fraction (LVEF)
Patients will undergo echocardiography at 1, 7 and 40 days to assess Left Ventricle Ejection Fraction
Change of Signal Averaged ECG
Patients will undergo a 12-lead electrocardiogram at 1, 7 and 40 days
Change of T Wave alternans and equal indexes derived from holter monitoring
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
Change of QT duration
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
Pain assessment
Pain scores will be assessed on postoperative days 0-7 using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded into the medical record by the nurse monitoring the subject as part of standard care
Number of participants with adverse effects
Number of participants with pruritus, flush, pain at the stimulation site

Full Information

First Posted
January 30, 2023
Last Updated
February 20, 2023
Sponsor
Hippocration General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05750108
Brief Title
Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction
Acronym
EARLY-VAGUS
Official Title
Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hippocration General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
Among patients early following ST-segment (ST) elevation myocardial infarction, transcutaneous vagus nerve stimulation is associated with a reduce of the burden of premature ventricular contractions in the first 40 days post-myocardial infarction (MI). The above hypothesis will be tested with a randomized, prospective, parallel, single-blind clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for June 2023) to the time of study's termination date (December 2024). Patient enrollment is planned to take place at two major centers in Greece. The researchers will obtain approval by the institutional review board (IRB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Tachyarrhythmia
Keywords
transcutaneous vagal nerve stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Transcutaneous Vagal Nerve Stimulation
Arm Type
Active Comparator
Arm Title
Sham Transcutaneous Vagal Nerve Stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Parasym device (active, current (mA) < discomfort threshold)
Intervention Description
Active transcutaneous Vagal Nerve Stimulation (tVNS) (Parasym device, Parasym Health, Inc, London, UK) will be performed with a clip attached to the ear at 20 hertz (Hz), 250 microseconds (ms) at a current just below discomfort threshold for 30 minutes twice a day, starting on post-MI day 0. Stimulation will continue until 7 days post-MI or discharge.
Intervention Type
Device
Intervention Name(s)
Parasym device (sham, current (mA) = 0)
Intervention Description
Parasym device will be attached to the ear twice a day, turned on but current set to 0 milliamp (mA), starting on post-MI day 0. Stimulation will continue until 7 days post-MI or discharge.
Primary Outcome Measure Information:
Title
Change of Ventricular tachycardia burden
Description
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate their number of Premature ventricular contractions (PVCs) and number of Non-Sustain Ventricular Tachycardias (NSVT).
Time Frame
1, 7 and 40 days follow-up
Secondary Outcome Measure Information:
Title
Change of Heart Rate Variability
Description
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Variability
Time Frame
1, 7 and 40 days follow-up
Title
Change of Heart Rate Turbulence
Description
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Turbulence
Time Frame
1, 7 and 40 days follow-up
Title
Change of Deceleration Capacity (DC)
Description
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Deceleration Capacity
Time Frame
1, 7 and 40 days follow-up
Title
Change of Echocardiographic strain
Description
Patients will undergo echocardiography at 1, 7 and 40 days to assess Myocardial substrate lesions and Post-infraction fibrosis
Time Frame
1, 7 and 40 days follow-up
Title
Change of Left Ventricle Ejection Fraction (LVEF)
Description
Patients will undergo echocardiography at 1, 7 and 40 days to assess Left Ventricle Ejection Fraction
Time Frame
1, 7 and 40 days follow-up
Title
Change of Signal Averaged ECG
Description
Patients will undergo a 12-lead electrocardiogram at 1, 7 and 40 days
Time Frame
1, 7 and 40 days follow-up
Title
Change of T Wave alternans and equal indexes derived from holter monitoring
Description
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
Time Frame
1, 7 and 40 days follow-up
Title
Change of QT duration
Description
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
Time Frame
1, 7 and 40 days follow-up
Title
Pain assessment
Description
Pain scores will be assessed on postoperative days 0-7 using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded into the medical record by the nurse monitoring the subject as part of standard care
Time Frame
7 days follow-up
Title
Number of participants with adverse effects
Description
Number of participants with pruritus, flush, pain at the stimulation site
Time Frame
7 days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged ≥18 years ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule Exclusion Criteria: A patient will be excluded from the study if one or more of all the following criteria are present: < 3 months after prior ablation Patients on amiodarone Patients with known thyroid issues, on renal-dialysis Life expectancy of < 12 months Complex congenital heart disease Cardiogenic shock Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker Complete heart block or trifascicular block without an implantable pacemaker Recurrent vasovagal syncope Pre-existing implantable cardioverter-defibrillator (ICD) Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded)) On the heart transplant list Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications) Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Tsioufis, Professor
Phone
2132088000
Email
ktsioufis@hippocratio.gr
Facility Information:
Facility Name
Heart Rhythm Institute, University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stavros Stavrakis, MD, PhD
Email
Stavros-stavrakis@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Stavros Stavrakis
Facility Name
First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11527
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Tsioufis, Professor
Phone
2132088000
Email
ktsioufis@hippocratio.gr
First Name & Middle Initial & Last Name & Degree
Ioannis Doundoulakis, MD, MSc (Res)
First Name & Middle Initial & Last Name & Degree
Konstantinos Tsioufis, Professor
First Name & Middle Initial & Last Name & Degree
Panagiotis Tsioufis, MD, MSc
Facility Name
Athens Heart Center Amarousion
City
Athens
State/Province
Attiki
ZIP/Postal Code
15125
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitrios Tsiachris, MD
Email
dtsiachris@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dimitrios Tsiachris
Facility Name
Biomedical Engineering, Khalifa University of Science and Technology
City
Abu Dhabi
Country
United Arab Emirates
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leontios Hadjileontiadis
Email
leontios.hadjileontiadis@ku.ac.ae
First Name & Middle Initial & Last Name & Degree
Leontios Hadjileontiadis

12. IPD Sharing Statement

Learn more about this trial

Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction

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