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TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)

Primary Purpose

Coronary Artery Disease, Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Temporary spinal cord stimulation
Coronary artery bypass grafting
B-blockers
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MedElect ClinicRecruiting
  • Novosibirsk Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CABG + b-blockers

CABG + b-blockers + temporary SCS

Arm Description

Standart coronary artery bypass grafting is performed with b-blockers treatment. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.

Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.

Outcomes

Primary Outcome Measures

Occurrence of adverse events
MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury
Occurrence of atrial tachyarrhythmias
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec during 30 days after surgery
Occurrence of tachyarrhythmias
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery

Secondary Outcome Measures

Marker of myocardial injury - high-sensitive Troponin I
Marker of myocardial injury - CK-MB
Marker of kidney injury - Creatinine
Hemodynamic parameter - Blood pressure
Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure
Hemodynamic parameter - Heart rate
Hemodynamic parameter - Cardiac index
Hemodynamic parameter - Vascular resistance
Systemic vascular resistance, pulmonary artery resistance
Acute pain assessment
The Wong-Baker Faces Pain Rating Scale
Inotropic score
Duration of mechanical ventilation
Duration of intensive care unit stay
Renal-replacement therapy

Full Information

First Posted
April 23, 2018
Last Updated
July 3, 2018
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT03539354
Brief Title
TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery
Acronym
TerminationAF
Official Title
TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Atrial Fibrillation
Keywords
Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CABG + b-blockers
Arm Type
Active Comparator
Arm Description
Standart coronary artery bypass grafting is performed with b-blockers treatment. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
Arm Title
CABG + b-blockers + temporary SCS
Arm Type
Experimental
Arm Description
Before coronary artery bypass grafting in the experimental group, 3 days of temporary spinal cord stimulation is performed than device turned off and coronary artery bypass grafting procedure is made. The device for spinal cord is turned on in intensive care unit for 7 days. Continuous ECG during intensive care unit stay, daily ECG, and 24-h Holter monitor recordings will be performed at 7, 14, 21, and 30 days after coronary artery bypass grafting, external loop recorder after discharge from intensive care unit till 30 days after coronary artery bypass grafting.
Intervention Type
Device
Intervention Name(s)
Temporary spinal cord stimulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting
Intervention Description
Standart coronary artery bypass grafting procedure.
Intervention Type
Drug
Intervention Name(s)
B-blockers
Intervention Description
Standart b-blocker therapy will be administered in each group for AF prophylactics
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Description
MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury
Time Frame
30 days
Title
Occurrence of atrial tachyarrhythmias
Description
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec during 30 days after surgery
Time Frame
30 days
Title
Occurrence of tachyarrhythmias
Description
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Marker of myocardial injury - high-sensitive Troponin I
Time Frame
30 days
Title
Marker of myocardial injury - CK-MB
Time Frame
30 days
Title
Marker of kidney injury - Creatinine
Time Frame
30 days
Title
Hemodynamic parameter - Blood pressure
Description
Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure
Time Frame
30 days
Title
Hemodynamic parameter - Heart rate
Time Frame
30 days
Title
Hemodynamic parameter - Cardiac index
Time Frame
30 days
Title
Hemodynamic parameter - Vascular resistance
Description
Systemic vascular resistance, pulmonary artery resistance
Time Frame
30 days
Title
Acute pain assessment
Description
The Wong-Baker Faces Pain Rating Scale
Time Frame
30 days
Title
Inotropic score
Time Frame
30 days
Title
Duration of mechanical ventilation
Time Frame
30 days
Title
Duration of intensive care unit stay
Time Frame
30 days
Title
Renal-replacement therapy
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander B Romanov, PhD
Phone
+79137172652
Email
abromanov@mail.ru
Facility Information:
Facility Name
MedElect Clinic
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Yakovlev
Facility Name
Novosibirsk Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Ponomrenko, MD
Phone
+79628316017
Email
andreyvictorovich92@mail.ru
First Name & Middle Initial & Last Name & Degree
Igor Mikheenko, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35177200
Citation
Romanov A, Lomivorotov V, Chernyavskiy A, Murtazin V, Kliver E, Ponomarev D, Mikheenko I, Yakovlev A, Yakovleva M, Steinberg JS. Temporary Spinal Cord Stimulation to Prevent Postcardiac Surgery Atrial Fibrillation: 30-Day Safety and Efficacy Outcomes. J Am Coll Cardiol. 2022 Feb 22;79(7):754-756. doi: 10.1016/j.jacc.2021.08.078. No abstract available.
Results Reference
derived

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TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery

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