Myocardial InfarctionEARLY-VAGUSNCT05750108
Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction
A study testing Parasym device (active, current (mA) < discomfort threshold) in people with Myocardial Infarction and Tachyarrhythmia, run by Hippocration General Hospital at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Tachyarrhythmia
- What is being tested?
- Parasym device (active, current (mA) < discomfort threshold)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Greece2 sites
First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens
Athens, Attica, 11527
Konstantinos Tsioufis, Professor, 2132088000, ktsioufis@hippocratio.gr
Ioannis Doundoulakis, MD, MSc (Res)
Athens Heart Center Amarousion
Athens, Attica, 15125
Dimitrios Tsiachris, MD, dtsiachris@yahoo.com
Dimitrios Tsiachris
United States1 site
Heart Rhythm Institute, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Stavros Stavrakis, MD, PhD, Stavros-stavrakis@ouhsc.edu
Stavros Stavrakis
United Arab Emirates1 site
Biomedical Engineering, Khalifa University of Science and Technology
Abu Dhabi
Leontios Hadjileontiadis, leontios.hadjileontiadis@ku.ac.ae
Leontios Hadjileontiadis
About this study
Official title: Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial
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).
- Conditions
- Myocardial Infarction, Tachyarrhythmia
- Being tested
- Parasym device (active, current (mA) < discomfort threshold), Parasym device (sham, current (mA) = 0)
- Keywords
- transcutaneous vagal nerve stimulation
- Medical subject headings
- Myocardial Infarction, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasym device (active, current (mA) < discomfort threshold)Device
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.
Parasym device (sham, current (mA) = 0)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Transcutaneous Vagal Nerve Stimulation | Active comparator | Not described Receives: Device: Parasym device (active, current (mA) < discomfort threshold) |
| Sham Transcutaneous Vagal Nerve Stimulation | Sham comparator | Not described Receives: Device: Parasym device (sham, current (mA) = 0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1, 7 and 40 days follow-up
Secondary outcomes (10)
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
Measured: 1, 7 and 40 days follow-up
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
Measured: 1, 7 and 40 days follow-up
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
Measured: 1, 7 and 40 days follow-up
Change of Echocardiographic strain
Patients will undergo echocardiography at 1, 7 and 40 days to assess Myocardial substrate lesions and Post-infraction fibrosis
Measured: 1, 7 and 40 days follow-up
Change of Left Ventricle Ejection Fraction (LVEF)
Patients will undergo echocardiography at 1, 7 and 40 days to assess Left Ventricle Ejection Fraction
Measured: 1, 7 and 40 days follow-up
Change of Signal Averaged ECG
Patients will undergo a 12-lead electrocardiogram at 1, 7 and 40 days
Measured: 1, 7 and 40 days follow-up
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
Measured: 1, 7 and 40 days follow-up
Change of QT duration
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
Measured: 1, 7 and 40 days follow-up
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
Measured: 7 days follow-up
Number of participants with adverse effects
Number of participants with pruritus, flush, pain at the stimulation site
Measured: 7 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Tsioufis, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750108
- Sponsor's protocol ID
- EARLY-VAGUS
- Acronym
- EARLY-VAGUS
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05750108
- Acronym / sponsor ID
- EARLY-VAGUS / EARLY-VAGUS
- Conditions
- Myocardial Infarction, Tachyarrhythmia
- Keywords
- transcutaneous vagal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcutaneous Vagal Nerve Stimulation | Active comparator | Device: Parasym device (active, current (mA) < discomfort threshold) |
| Sham Transcutaneous Vagal Nerve Stimulation | Sham comparator | Device: Parasym device (sham, current (mA) = 0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasym device (active, current (mA) < discomfort threshold)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. | Device | Active Transcutaneous Vagal Nerve Stimulation |
| Parasym device (sham, current (mA) = 0)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. | Device | Sham Transcutaneous Vagal Nerve Stimulation |
Primary outcome
Change of Ventricular tachycardia burden
Time frame: 1, 7 and 40 days follow-up
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).
10 secondary outcomes
Change of Heart Rate Variability
Time frame: 1, 7 and 40 days follow-up
Change of Heart Rate Turbulence
Time frame: 1, 7 and 40 days follow-up
Change of Deceleration Capacity (DC)
Time frame: 1, 7 and 40 days follow-up
Change of Echocardiographic strain
Time frame: 1, 7 and 40 days follow-up
Change of Left Ventricle Ejection Fraction (LVEF)
Time frame: 1, 7 and 40 days follow-up
Change of Signal Averaged ECG
Time frame: 1, 7 and 40 days follow-up
Change of T Wave alternans and equal indexes derived from holter monitoring
Time frame: 1, 7 and 40 days follow-up
Change of QT duration
Time frame: 1, 7 and 40 days follow-up
Pain assessment
Time frame: 7 days follow-up
Number of participants with adverse effects
Time frame: 7 days follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym device (active, current (mA) < discomfort threshold) in people with Myocardial Infarction and Tachyarrhythmia, run by Hippocration General Hospital at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, United States, United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Tsioufis, Professor (2132088000, ktsioufis@hippocratio.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Ventricular tachycardia burden (time frame: 1, 7 and 40 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.