Atrial Fibrillation, Coronary Artery Disease
Conditions
Keywords
Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting
Brief summary
To compare of atrial arrhythmia incidence in patients with coronary artery disease and atrial fibrillation history, undergoing either coronary artery bypass grafting plus temporary spinal cord stimulation or coronary artery bypass grafting alone
Detailed description
The study includes 60 patients. Patients are randomized into 2 groups: coronary artery bypass grafting plus b-blocker treatment (according to guidelines; group I) and coronary artery bypass grafting plus b-blocker treatment (according to guidelines) plus temporary spinal cord stimulation (group 2). Temporary spinal cord stimulation is performed for 3 days before surgery and 7 days after coronary artery bypass grafting. Continuous ECG during intensive care unit stay, daily ECG and 24-h Holter monitor recordings at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit until 30 days after coronary artery bypass grafting. Rhythm status and clinical outcome assessment at 12 month follow up
Interventions
DEVICETemporary spinal cord stimulation
Percutaneous trial (temporary) electrodes are placed through a 14-gauge needle.The skin is entered at the medial aspect of the pedicle with the Tuohy needle usually angled 30-45° toward the midline for optimal entry into the epidural space at the interlaminar edge 1 or 2 levels of cephalad (usually, Th5-Th6 level). The 14-gauge needle is then passed with the bevel facing up at a 30-45° oblique angle to reach the depth of the midline laminar target.The Tuohy needle is then carefully removed and the operative site is cleaned with chlorhexidine and alcohol. Temporary stimulation is carried out till coronary artery bypass grafting surgery for 3 days, then stimulation turns off during surgery. At the end of coronary artery bypass grafting the temporary stimulation turns on in the intensive care unit and continues for 7 days. After that, the temporary leads will be removed.
PROCEDURECoronary artery bypass grafting
Standart coronary artery bypass grafting procedure.
DRUGB-blockers
Standart b-blocker therapy will be administered in each group for AF prophylactics
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18-80 years; * indications for coronary artery bypass grafting according to guidelines; * pre-operative history of paroxysmal atrial fibrillation; * absent of contraindications for spinal cord stimulation; * signed inform consent.
Exclusion criteria
* previous heart surgery or atrial fibrillation ablation procedure; * emergency coronary artery bypass grafting; * left ventricle ejection fraction \<35%; * unstable angina or heart failure; * persistent atrial fibrillation or atrial fibrillation at the time of screening; * planned Maze procedure or pulmonary vein isolation; * use of class I or III antiarrhythmic drugs within 5 elimination half-lives of the drug; * need for concomitant valve surgery; * Inability to control the device for spinal cord stimulation; * coagulopathy, immunosuppression, or other condition associated with an unacceptable surgical risk for spinal cord stimulation; * Need for therapeutic diathermy in the area of leads placement; * Need for pacemaker/ICD/CRT-D implantation; * unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of adverse events | 30 days | MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury |
| Occurrence of atrial tachyarrhythmias | 30 days | Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec during 30 days after surgery |
| Occurrence of tachyarrhythmias | 12 months | Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic parameter - Blood pressure | 30 days | Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure |
| Hemodynamic parameter - Heart rate | 30 days | — |
| Hemodynamic parameter - Cardiac index | 30 days | — |
| Hemodynamic parameter - Vascular resistance | 30 days | Systemic vascular resistance, pulmonary artery resistance |
| Marker of myocardial injury - high-sensitive Troponin I | 30 days | — |
| Inotropic score | 30 days | — |
| Duration of mechanical ventilation | 30 days | — |
| Duration of intensive care unit stay | 30 days | — |
| Renal-replacement therapy | 30 days | — |
| Acute pain assessment | 30 days | The Wong-Baker Faces Pain Rating Scale |
| Marker of myocardial injury - CK-MB | 30 days | — |
| Marker of kidney injury - Creatinine | 30 days | — |
Countries
Russia
Contacts
Primary ContactAlexander B Romanov, PhD
Outcome results
None listed