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Effects of Magnesium on Individuals Undergoing Coronary Artery Bypass Graft Surgery (POINT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00041392
First Posted: July 9, 2002
Last Update Posted: July 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention Phase
Coronary Disease Heart Diseases Cardiovascular Diseases Neurologic Manifestations Drug: Magnesium Drug: 0.9% saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: PeriOperative Interventional Neuroprotection Trial (POINT)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Enrollment: 389
Study Start Date: December 2001
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Magnesium
100 mg/kg magnesium
Drug: Magnesium
100 mg/kg
Placebo Comparator: 0.9 % saline
100 mg/kg 0.9 % saline
Drug: 0.9% saline
Placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary heart disease

Exclusion Criteria:

  • Early dementia
  • History of psychiatric illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041392


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Mark F. Newman, MD Duke University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00041392     History of Changes
Other Study ID Numbers: Pro00007128
R01HL069081 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2002
First Posted: July 9, 2002
Results First Submitted: August 5, 2012
Results First Posted: October 30, 2012
Last Update Posted: July 30, 2013
Last Verified: April 2012

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Neurologic Manifestations
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Nervous System Diseases
Signs and Symptoms