Atrial FibrillationPhase 4POMAF-CSNCT03703349
Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)
A Phase 4 study testing Magnesium Sulfate in people with Atrial Fibrillation and Coronary Artery Disease, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
Trial summary
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease, Surgery--Complications
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteLebanon
- Study dates
- 24 Nov 2018to 20 Oct 2019
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Coronary artery disease
- Planned coronary artery surgery
- signed informed consent
Who cannot join
- Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic
- Left ventricular EF < 30%
- Urgent surgery
- Redo surgery
- Permanent preoperative pacemaker
- Preoperative anti arrythmia drugs classes I and III
Show all 12Show fewer
- Post operative inotrope drugs
- Postoperative bradycardia necessitating electrosystolic pacing
- Preoperative heart rate less than 50 bpm
- documented preoperative dysthryroidism
- 2nd and 3rd degree atrioventricular bloc
- Renal failure with GFR < 30 ml/min/1.73 m²
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients.
Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial.
Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery.
The occurrence of POAF will be studied as a main outcome.
Read the detailed description
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization.
Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF.
Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups:
- Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
- Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
The anesthetic and surgical management protocols will be identical for both groups. The occurrence of POAF during the 7 postoperative days, the main outcome of the study, will be recorded, including the number of POAF episodes, their duration, recurrence, and the associated ventricular response rate. From a safety point, the occurrence of complications and the length of hospital stay will be noted.
- Being tested
- Magnesium Sulfate, Placebo Oral Tablet
- Keywords
- Coronary artery surgery, oral magnesium, atrial fibrillation, Randomized controlled trial
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called Magnesium
Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery
Placebo Oral TabletDrug
Also called Placebo
Placebo for Magnesium
| Study group | Role | What they receive |
|---|---|---|
| Preoperative oral Magnesium | Experimental | Magnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention Receives: Drug: Magnesium Sulfate |
| Control | Placebo comparator | Placebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative atrial fibrillation
New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
Measured: 7 postoperative days
Secondary outcomes (2)
Ventricular response rate
Average ventricular rate during atrial fibrillation episodes
Measured: During the atrial fibrillation episodes
Recurrence of atrial fibrillation
Relapse of atrial fibrillation following the initial episode
Measured: 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start24 Nov 2018
- Primary completion20 Oct 2019
- Study completion20 Oct 2019
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 Atrial FibrillationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to the 2 groups of treatment by blocks of 8. The randomization list will be computer-generated, with no factors for stratification. To reduce predictability of the random sequence, blocking will be made unavailable to those who assign interventions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Madi Jebara, St Joseph University, Beirut, Lebanon
- Investigators
- Samia N Madi-Jebara, Principal investigator, Saint-Joseph University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703349
- Sponsor's protocol ID
- CEHDF 850
- Acronym
- POMAF-CS
- Status last verified
- Apr 2020
- First submitted
- 9 Oct 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be made available upon request from researchers who need to perform a meta analysis on the subject. IPD will be sent directly to the requesting party
Publications
Tohme J, Sleilaty G, Jabbour K, Gergess A, Hayek G, Jebara V, Madi-Jebara S. Preoperative oral magnesium loading to prevent postoperative atrial fibrillation following coronary surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac269. doi: 10.1093/ejcts/ezac269.
PubMed 35451469
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Magnesium Versus Standard of Care to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03703349
- Acronym / sponsor ID
- POMAF-CS / CEHDF 850
- Keywords
- Coronary artery surgery, oral magnesium, atrial fibrillation, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- 24 Nov 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 11 Oct 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.
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients.
Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial.
Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery.
The occurrence of POAF will be studied as a main outcome.
Detailed description
Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. It is associated with many complications. POAF increases the postoperative length of stay and increases the cost of hospitalization.
Several studies and meta-analyzes have demonstrated the beneficial effect of intravenous magnesium (Mg), administered per-or post-operatively, in reducing the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied.
The aim of this study is to study the effect of oral Mg, administered preoperatively, on the incidence of POAF.
Following IRB approval, 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Patients will be allocated inn a 1: 1 ratio in 2 groups:
- Treatment group will receive preoperatively 8 tablets of Mg (3.2 g) per day, at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
- Control group will receive 8 tablets of placebo daily,at day (-3), day (-2), and day (-1) before the day of planned coronary artery surgery.
The anesthetic and surgical management protocols will be identical for both groups. The occurrence of POAF during the 7 postoperative days, the main outcome of the study, will be recorded, including the number of POAF episodes, their duration, recurrence, and the associated ventricular response rate. From a safety point, the occurrence of complications and the length of hospital stay will be noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to the 2 groups of treatment by blocks of 8. The randomization list will be computer-generated, with no factors for stratification. To reduce predictability of the random sequence, blocking will be made unavailable to those who assign interventions.
| Arm | Type | Receives |
|---|---|---|
| Preoperative oral Magnesium | Experimental | Drug: Magnesium SulfateMagnesium sulfate 8 tablets (8 x 0.4 g) per day, PO, for the 3 days preceding the surgical intervention |
| Control | Placebo comparator | Drug: Placebo Oral TabletPlacebo oral tablet, for Magnesium Sulfate tablets, PO, for the 3 days preceding the surgical intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Coronary artery disease
- Planned coronary artery surgery
- signed informed consent
Key exclusion criteria (12 listed)
- Preoperative supraventricular dysrhythmia including atrial fibrillation, either acute or chronic
- Left ventricular EF < 30%
- Urgent surgery
- Redo surgery
- Permanent preoperative pacemaker
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 |
|---|---|---|
| Magnesium SulfateAlso: MagnesiumMagnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery | Drug | Preoperative oral Magnesium |
| Placebo Oral TabletAlso: PlaceboPlacebo for Magnesium | Drug | Control |
Primary outcome
postoperative atrial fibrillation
Time frame: 7 postoperative days
New onset of atrial fibrillation clinically or telemetry detected and confirmed by EKG
2 secondary outcomes
Ventricular response rate
Time frame: During the atrial fibrillation episodes
Recurrence of atrial fibrillation
Time frame: 7 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Derived from this study: PubMed 35451469Tohme J, Sleilaty G, Jabbour K, Gergess A, Hayek G, Jebara V, Madi-Jebara S. Preoperative oral magnesium loading to prevent postoperative atrial fibrillation following coronary surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac269. doi: 10.1093/ejcts/ezac269.
- Individual participant dataSharing planned: Undecided. IPD will be made available upon request from researchers who need to perform a meta analysis on the subject. IPD will be sent directly to the requesting party
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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.
Samia N Madi-Jebara principal investigator
Saint-Joseph University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate in people with Atrial Fibrillation and Coronary Artery Disease, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative atrial fibrillation (time frame: 7 postoperative days). 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 NCT03703349, 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 28 Apr 2020.