Coronary Artery DiseaseTerminationAFNCT03539354
TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery
A study testing Temporary spinal cord stimulation, Coronary artery bypass grafting and B-blockers in people with Coronary Artery Disease and Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation
- What is being tested?
- Temporary spinal cord stimulation, Coronary artery bypass grafting and B-blockers
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jul 2018to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
MedElect Clinic
Moscow
Alexander Yakovlev
- Recruiting
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055
Andrey Ponomrenko, MD, +79628316017, andreyvictorovich92@mail.ru
Igor Mikheenko, MD
About this study
Official title: TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)
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
Read the 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
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Being tested
- Temporary spinal cord stimulation, Coronary artery bypass grafting, B-blockers
- Keywords
- Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary spinal cord stimulationDevice
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.
Coronary artery bypass graftingProcedure or surgery
Standart coronary artery bypass grafting procedure.
B-blockersDrug
Standart b-blocker therapy will be administered in each group for AF prophylactics
| Study group | Role | What they receive |
|---|---|---|
| CABG + b-blockers | Active comparator | 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. Receives: Procedure: Coronary artery bypass grafting; Drug: B-blockers |
| CABG + b-blockers + temporary SCS | Experimental | 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. Receives: Device: Temporary spinal cord stimulation; Procedure: Coronary artery bypass grafting; Drug: B-blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury
Measured: 30 days
Occurrence of atrial tachyarrhythmias
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec during 30 days after surgery
Measured: 30 days
Occurrence of tachyarrhythmias
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery
Measured: 12 months
Secondary outcomes (12)
Marker of myocardial injury - high-sensitive Troponin I
Measured: 30 days
Marker of myocardial injury - CK-MB
Measured: 30 days
Marker of kidney injury - Creatinine
Measured: 30 days
Hemodynamic parameter - Blood pressure
Invasive blood pressure, pulmonary artery pressure, central venous pressure, pulmonary artery wedge pressure
Measured: 30 days
Hemodynamic parameter - Heart rate
Measured: 30 days
Hemodynamic parameter - Cardiac index
Measured: 30 days
Hemodynamic parameter - Vascular resistance
Systemic vascular resistance, pulmonary artery resistance
Measured: 30 days
Acute pain assessment
The Wong-Baker Faces Pain Rating Scale
Measured: 30 days
Inotropic score
Measured: 30 days
Duration of mechanical ventilation
Measured: 30 days
Duration of intensive care unit stay
Measured: 30 days
Renal-replacement therapy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539354
- Sponsor's protocol ID
- TERMAF1
- Acronym
- TerminationAF
- Status last verified
- Jul 2018
- First submitted
- 23 Apr 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35177200
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF)
- ClinicalTrials.gov ID
- NCT03539354
- Acronym / sponsor ID
- TerminationAF / TERMAF1
- Conditions
- Coronary Artery Disease, Atrial Fibrillation
- Keywords
- Atrial fibrillation, Spinal cord stimulatoin, Coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG + b-blockers | Active comparator | Procedure: Coronary artery bypass grafting, Drug: B-blockersStandart 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. |
| CABG + b-blockers + temporary SCS | Experimental | Device: Temporary spinal cord stimulation, Procedure: Coronary artery bypass grafting, Drug: B-blockersBefore 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary spinal cord stimulationPercutaneous 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. | Device | CABG + b-blockers + temporary SCS |
| Coronary artery bypass graftingStandart coronary artery bypass grafting procedure. | Procedure or surgery | CABG + b-blockers, CABG + b-blockers + temporary SCS |
| B-blockersStandart b-blocker therapy will be administered in each group for AF prophylactics | Drug | CABG + b-blockers, CABG + b-blockers + temporary SCS |
Primary outcome
Occurrence of adverse events
Time frame: 30 days
MACE (Death, Stroke/TIA, Myocardial infarction), acute kidney injury, spinal cord injury
Occurrence of atrial tachyarrhythmias
Time frame: 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
Time frame: 12 months
Occurrence of any atrial tachyarrhythmias including atrial fibrillation, atrial tachycardia, atrial flutter lasting ≥ 30 sec 30 days after surgery
12 secondary outcomes
Marker of myocardial injury - high-sensitive Troponin I
Time frame: 30 days
Marker of myocardial injury - CK-MB
Time frame: 30 days
Marker of kidney injury - Creatinine
Time frame: 30 days
Hemodynamic parameter - Blood pressure
Time frame: 30 days
Hemodynamic parameter - Heart rate
Time frame: 30 days
Hemodynamic parameter - Cardiac index
Time frame: 30 days
Hemodynamic parameter - Vascular resistance
Time frame: 30 days
Acute pain assessment
Time frame: 30 days
Inotropic score
Time frame: 30 days
Duration of mechanical ventilation
Time frame: 30 days
Duration of intensive care unit stay
Time frame: 30 days
Renal-replacement therapy
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 35177200Romanov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary spinal cord stimulation, Coronary artery bypass grafting and B-blockers in people with Coronary Artery Disease and Atrial Fibrillation, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander B Romanov, PhD (+79137172652, abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.