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Correlation Between Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Surgery

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ClinicalTrials.gov Identifier: NCT01550159
Recruitment Status : Unknown
Verified March 2012 by Maria José Carvalho Carmona, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Maria José Carvalho Carmona, University of Sao Paulo

Tracking Information
First Submitted Date February 6, 2012
First Posted Date March 9, 2012
Last Update Posted Date March 9, 2012
Study Start Date April 2009
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 6, 2012)
Score in Neuropsycological Tests [ Time Frame: 1 year ]
Tests for evaluation of quality of life, depressive synths and neuropsycho;logical battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive ask and recall, including processing speed. This assessment will be applied before surgery, and 3, 7,21 90 and 180 days after surgery.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlation Between Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Surgery
Official Title Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Graft Surgery
Brief Summary This study aims to evaluate the possible Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.
Detailed Description The systemic inflammatory response after cardiac surgery may cause damage to the central nervous system and elevated markers of brain injury in peripheral blood. This event may be potentially related to the development of postoperative cognitive dysfunction (POCD), with incidences varying from 20 to 83%.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients underwent for coronary artery bypass graft surgery.
Condition Postoperative Cognitive Dysfunction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Silva FP, Schmidt AP, Valentin LS, Pinto KO, Zeferino SP, Oses JP, Wiener CD, Otsuki DA, Tort AB, Portela LV, Souza DO, Auler JO Jr, Carmona MJ. S100B protein and neuron-specific enolase as predictors of cognitive dysfunction after coronary artery bypass graft surgery: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):681-9. doi: 10.1097/EJA.0000000000000450.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 6, 2012)
88
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2013
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients underwent for coronary artery bypass graft surgery

Exclusion Criteria:

  • History of brain disease or dementia, other psychiatric disorders that affect cognition
  • Lack of proficiency in Portuguese language
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01550159
Other Study ID Numbers 1081/04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maria José Carvalho Carmona, University of Sao Paulo
Study Sponsor Maria José Carvalho Carmona
Collaborators Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Maria JC Carmona, MD University of Sao Paulo Medical School
PRS Account University of Sao Paulo
Verification Date March 2012