Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Transcutaneous Vagal Nerve Stimulation | Active Comparator |
| |
| Sham Transcutaneous Vagal Nerve Stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change of Heart Rate Turbulence |
Not provided
Inclusion Criteria:
Exclusion Criteria:
A patient will be excluded from the study if one or more of all the following criteria are present:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantinos Tsioufis, Professor | Contact | 2132088000 | ktsioufis@hippocratio.gr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Rhythm Institute, University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of participants with adverse effects | Number of participants with pruritus, flush, pain at the stimulation site | 7 days follow-up |
| First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens | Athens | Attica | 11527 | Greece |
|
| Athens Heart Center Amarousion | Athens | Attica | 15125 | Greece |
|
| Biomedical Engineering, Khalifa University of Science and Technology | Abu Dhabi | United Arab Emirates |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
Not provided
Not provided