Coronary DiseasePhase 2POINTNCT00041392
Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery
A Phase 2 study testing Magnesium and 0.9% saline in people with Coronary Disease and Heart Diseases, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Coronary Disease, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Magnesium and 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 389 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary heart disease
Who cannot join
- Early dementia
- History of psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: PeriOperative Interventional Neuroprotection Trial (POINT)
The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.
Read the detailed description
BACKGROUND:
Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.
DESIGN NARRATIVE:
This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.
- Being tested
- Magnesium, 0.9% saline
- Medical subject headings
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
100 mg/kg
0.9% salineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Active comparator | 100 mg/kg magnesium Receives: Drug: Magnesium |
| 0.9 % saline | Placebo comparator | 100 mg/kg 0.9 % saline Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.
Measured: Measured at baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2002 (estimated)
- Study startDec 2001
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mark F. Newman, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041392
- Sponsor's protocol ID
- Pro00007128
- Other IDs
- R01HL069081
- Acronym
- POINT
- Status last verified
- Apr 2012
- First submitted
- 8 Jul 2002
- Last updated
- 30 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mathew JP, White WD, Schinderle DB, Podgoreanu MV, Berger M, Milano CA, Laskowitz DT, Stafford-Smith M, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of The Duke Heart Center. Intraoperative magnesium administration does not improve neurocognitive function after cardiac surgery. Stroke. 2013 Dec;44(12):3407-13. doi: 10.1161/STROKEAHA.113.002703. Epub 2013 Oct 8.
PubMed 24105697
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeriOperative Interventional Neuroprotection Trial (POINT)
- ClinicalTrials.gov ID
- NCT00041392
- Acronym / sponsor ID
- POINT / Pro00007128
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2001
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Jul 2002 (estimated)
- Results
- Posted 30 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of supplemental magnesium on the neurocognitive function of individuals undergoing coronary artery bypass graft (CABG) surgery.
Detailed description
BACKGROUND:
Approximately 400,000 individuals undergo heart operations each year and cognitive impairment occurs frequently following surgery. An increasing number of these individuals are elderly and are particularly susceptible to cognitive dysfunction following surgery. Cognitive impairment is most notable in the early stages following heart surgery, but it may persist in some individuals. While many people think cognitive impairment is subtle, transient, or subclinical, perioperative decline is associated with 5-year cognitive deterioration and reduced quality of life. Multiple strategies, both clinical and pharmacological, have been proposed to reduce the central nervous system dysfunction associated with heart surgery. However, most strategies have been unsuccessful, met with limited success, or are unrealistic from a cost or risk-benefit ratio for the majority of people. This study will examine the effectiveness of supplemental magnesium at preventing the cognitive decline associated with heart surgery.
DESIGN NARRATIVE:
This study will examine the effect of supplemental magnesium on the neurocognitive function of individuals undergoing CABG surgery. The two hypotheses to be tested include the following: 1) therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after heart surgery; and 2) therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after heart surgery. This double-blind study will enroll 400 individuals and randomly assign them to either the treatment group, which will receive 100 mg/kg of magnesium, or to the control group. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted prior to surgery, and 6 weeks and 1 year following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Active comparator | Drug: Magnesium100 mg/kg magnesium |
| 0.9 % saline | Placebo comparator | Drug: 0.9% saline100 mg/kg 0.9 % saline |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary heart disease
Key exclusion criteria (2 listed)
- Early dementia
- History of psychiatric illness
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 |
|---|---|---|
| Magnesium100 mg/kg | Drug | Magnesium |
| 0.9% salinePlacebo | Drug | 0.9 % saline |
Primary outcome
Cognitive Function
Time frame: Measured at baseline and 6 weeks
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24105697Mathew JP, White WD, Schinderle DB, Podgoreanu MV, Berger M, Milano CA, Laskowitz DT, Stafford-Smith M, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of The Duke Heart Center. Intraoperative magnesium administration does not improve neurocognitive function after cardiac surgery. Stroke. 2013 Dec;44(12):3407-13. doi: 10.1161/STROKEAHA.113.002703. Epub 2013 Oct 8.
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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.
Mark F. Newman, MD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium and 0.9% saline in people with Coronary Disease and Heart Diseases, run by Duke University at 1 site in United States.
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 1 inclusion and 2 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 30 Jul 2013. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cognitive Function (time frame: Measured at baseline and 6 weeks). 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 NCT00041392, 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 30 Jul 2013.