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PeriOperative Interventional Neuroprotection Trial (POINT) - Article


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Choline Salicylate and Magnesium Salicylate

CMT; Tricosal; Trilisate 




Clinical Trial: PeriOperative Interventional Neuroprotection Trial (POINT)

This study is currently recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Purpose

To examine the effects of supplemental magnesium on the neurocognitive function of patients undergoing coronary artery bypass graft (CABG) surgery.

Condition Treatment or Intervention
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Neurologic Manifestations
 Drug: magnesium

MedlinePlus related topics:  Coronary Disease;   Heart Diseases;   Heart Diseases--Prevention;   Neurologic Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind

Further Study Details: 

Study start: December 2001;  Expected completion: November 2005

BACKGROUND: Cognitive impairment occurs frequently after surgery in the approximately 400,000 patients who undergo cardiac operations each year. An increasing number of these patients are elderly, and this patient population is particularly susceptible to cognitive dysfunction after cardiac surgery. Cognitive impairment is most notable in the early phases after cardiac surgery, but persistence occurs in an important percentage of patients. While adjectives such as "subtle," "transient," and "subclinical" have been used due to the apparent transient nature of decline, perioperative decline is associated with five 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 cardiac surgery. However, most have been unsuccessful, met with very limited success, or are unrealistic from a cost or risk-benefit ratio to be applied to the majority of patients. The trial tests the ability of supplemental magnesium to prevent the decline.

DESIGN NARRATIVE: The randomized trial examines the effects of supplemental magnesium on the neurocognitive function of patients undergoing CABG surgery. The hypotheses to be tested are: Therapeutic levels of magnesium reduce post-operative neurocognitive dysfunction after cardiac surgery; Therapeutic magnesium levels protect quality of life through reduced cognitive dysfunction after cardiac surgery. This clinical trial will enroll 400 patients and randomly assign them to one of two groups: treatment (100 mg/kg of magnesium) or control group with all the investigators and assessors blinded to group assignment. Anesthesia management will be standardized to minimize any impact that anesthesia may have on neurologic or neuropsychologic outcome. Neurocognitive testing will be conducted preoperatively (baseline), six-weeks and one year post-surgery.

Eligibility

Genders Eligible for Study:  Both

Criteria

Patients with coronary heart disease. Persons with early dementia and a history of psychiatric illness will be excluded.

Location and Contact Information


North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Elizabeth Tuazon, RN, BSN  919-681-2515    elizabeth.tuazon@duke.edu 
Mark F. Newman,  Study Chair

Study chairs or principal investigators

Mark Newman,  Duke University   

More Information

Study ID Numbers:  143
Record last reviewed:  December 2004
Last Updated:  January 10, 2005
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041392
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 28, 2009



Page Updated: June 1, 2005
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