Coronary Artery DiseasePhase 3NCT00250965
MPAACS: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
A Phase 3 study testing intravenous magnesium in people with Coronary Artery Disease and Valvular Heart Disease, run by University of British Columbia at 2 sites in Canada.
Trial summary
The objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- intravenous magnesium
- Type of treatment
- Injection or infusion
- How many people
- 927 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2004to Feb 2009
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing coronary artery bypass surgery with or without valve procedure
- scheduled for on-pump or cardiopulmonary bypass protocol
Who cannot join
- existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications
- ventricular fibrillation
- sustained ventricular tachycardia
- 2nd or 3rd degree heart block
- paroxysmal supraventricular tachycardia
- major aortic repair planned during open-heart procedure
Show all 11Show fewer
- permanent atrial/ventricular pacemaker implanted
- dialysis dependent or creatinine clearance < 35 umoles/min or oliguric/anuric renal failure
- patient intolerant of beta blockers
- patient has reactive airways disease dependent on regular beta-adrenergic agents
- patient is scheduled to undergo off-pump surgical protocol
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L7
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
The objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. A large, well-conducted study of magnesium treatment is required to definitively determine whether magnesium is effective in preventing this common complication after surgery. In addition, our study will include patients undergoing valvular surgery, a group previously excluded from research despite the fact that they are at increased risk of atrial fibrillation.
Read the detailed description
All patients referred for non-emergent cardiac surgery for isolated CABG, isolated valvular heart surgery, or combined valvular and CABG surgery are eligible for the study. Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily. Atrial fibrillation (and other arrhythmias) will be detected by placing all subjects on continuous 24-hour ECG telemetry monitoring for postoperative days 0 through 4.
The study is powered to detect at least a 30% relative reduction in postoperative atrial fibrillation in the CABG group; n=756. Because of the higher incidence of atrial fibrillation in the Valve +/- CABG group a total of 500 patients will be required to detect at least a 30% difference between treatment groups. These sample sizes are based on an alpha of 0.05 and 80% power.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- intravenous magnesium
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous magnesiumDrug
Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily.
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation
Measured: 0-4 days after surgery
Secondary outcomes (3)
stroke
Measured: 0-4 days after surgery
death
Measured: 0-4 days after surgery
myocardial infarction
Measured: 4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startJul 2004
- Primary completionSep 2008
- Study completionFeb 2009
Why it stopped: Terminated by DSMB; futility analysis showing Mg treatment not efficacious
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Karin H Humphries, DSc, Principal investigator, University of British Columbia/St. Paul's HospitalHubert Wong, PhD, Study chair, University of British Columbia, Department of Health Care & Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250965
- Sponsor's protocol ID
- 20R20015
- Status last verified
- Mar 2009
- First submitted
- 7 Nov 2005
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium for the Prevention of Atrial Arrhythmias After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00250965
- Acronym / sponsor ID
- 20R20015
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by DSMB; futility analysis showing Mg treatment not efficacious
- Enrolment
- 927 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Jul 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Nov 2005 (estimated)
- 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.
The objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. Several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. A large, well-conducted study of magnesium treatment is required to definitively determine whether magnesium is effective in preventing this common complication after surgery. In addition, our study will include patients undergoing valvular surgery, a group previously excluded from research despite the fact that they are at increased risk of atrial fibrillation.
Detailed description
All patients referred for non-emergent cardiac surgery for isolated CABG, isolated valvular heart surgery, or combined valvular and CABG surgery are eligible for the study. Subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily. Atrial fibrillation (and other arrhythmias) will be detected by placing all subjects on continuous 24-hour ECG telemetry monitoring for postoperative days 0 through 4.
The study is powered to detect at least a 30% relative reduction in postoperative atrial fibrillation in the CABG group; n=756. Because of the higher incidence of atrial fibrillation in the Valve +/- CABG group a total of 500 patients will be required to detect at least a 30% difference between treatment groups. These sample sizes are based on an alpha of 0.05 and 80% power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient undergoing coronary artery bypass surgery with or without valve procedure
- scheduled for on-pump or cardiopulmonary bypass protocol
Key exclusion criteria (11 listed)
- existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications
- ventricular fibrillation
- sustained ventricular tachycardia
- 2nd or 3rd degree heart block
- paroxysmal supraventricular tachycardia
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 |
|---|---|---|
| intravenous magnesiumSubjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. On postoperative days 1 through 4, subjects will receive either IV MgSO4 (5g in 250 ml normal saline) or IV placebo (250 ml normal saline) infusion over 4 hours daily. | Drug | – |
Primary outcome
atrial fibrillation
Time frame: 0-4 days after surgery
3 secondary outcomes
stroke
Time frame: 0-4 days after surgery
death
Time frame: 0-4 days after surgery
myocardial infarction
Time frame: 4 days after surgery
Results and safety
The study was stopped early (reason given: Terminated by DSMB; futility analysis showing Mg treatment not efficacious). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
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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.
Karin H Humphries, DSc principal investigator
University of British Columbia/St. Paul's Hospital
Hubert Wong, PhD study chair
University of British Columbia, Department of Health Care & Epidemiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous magnesium in people with Coronary Artery Disease and Valvular Heart Disease, run by University of British Columbia at 2 sites in Canada.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Nov 2010. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Terminated by DSMB; futility analysis showing Mg treatment not efficacious). Results are not available in the source record.
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?
atrial fibrillation (time frame: 0-4 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2010.