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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05750108
Other study ID # EARLY-VAGUS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2023
Est. completion date December 2024

Study information

Verified date February 2023
Source Hippocration General Hospital
Contact Konstantinos Tsioufis, Professor
Phone 2132088000
Email ktsioufis@hippocratio.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Device:
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.
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.

Locations

Country Name City State
Greece Athens Heart Center Amarousion Athens Attiki
Greece First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens Athens Attica
United Arab Emirates Biomedical Engineering, Khalifa University of Science and Technology Abu Dhabi
United States Heart Rhythm Institute, University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Hippocration General Hospital

Countries where clinical trial is conducted

United States,  Greece,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1, 7 and 40 days follow-up
Secondary 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 1, 7 and 40 days follow-up
Secondary 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 1, 7 and 40 days follow-up
Secondary 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 1, 7 and 40 days follow-up
Secondary Change of Echocardiographic strain Patients will undergo echocardiography at 1, 7 and 40 days to assess Myocardial substrate lesions and Post-infraction fibrosis 1, 7 and 40 days follow-up
Secondary Change of Left Ventricle Ejection Fraction (LVEF) Patients will undergo echocardiography at 1, 7 and 40 days to assess Left Ventricle Ejection Fraction 1, 7 and 40 days follow-up
Secondary Change of Signal Averaged ECG Patients will undergo a 12-lead electrocardiogram at 1, 7 and 40 days 1, 7 and 40 days follow-up
Secondary 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 1, 7 and 40 days follow-up
Secondary Change of QT duration Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days 1, 7 and 40 days follow-up
Secondary 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 7 days follow-up
Secondary Number of participants with adverse effects Number of participants with pruritus, flush, pain at the stimulation site 7 days follow-up
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