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The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP |
|
| Group 2 | Active Comparator | All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaceutical composition containing botulinum toxin | Drug |
| ||
| 0.9% normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any atrial tachyarrhythmias | Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of deaths | 12 month | |
| time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU | 1 month | |
| incidence of congestive heart failure |
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Inclusion Criteria:
Exclusion Criteria:
Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Romanov, MD, PhD | Contact | +73833327655 | abromanov@mail.ru | |
| Evgeny Pokushalov, MD, PhD | Contact | +73833327655 | E.Pokushalov@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of Circulation Pathology | Recruiting | Novosibirsk | 630055 | Russia |
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| Drug |
|
| Coronary artery bypass grafting | Procedure |
|
| 12 month |
| incidence of sustained ventricular arrhythmias | 12 month |
| stroke or transient ischemic attack | 12 month |
| incidence of myocardial infarction | 12 month |
| rehospitalization | 12 months |
| Cardiology Research Institute | Recruiting | Tomsk | Russia |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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