Cardiovascular Diseases Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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