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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Maria José Carvalho Carmona, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550159
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
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:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Maria José Carvalho Carmona, University of Sao Paulo
  Purpose
This study aims to evaluate the possible Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.

Condition
Postoperative Cognitive Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:


Further study details as provided by Maria José Carvalho Carmona, University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 88
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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%.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients underwent for coronary artery bypass graft surgery.
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
  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): NCT01550159


Contacts
Contact: Maria JC Carmona, M.D. 55-11-3069-6335 maria.carmona@incor.usp.br
Contact: Fernando CP Silva 55-11-3069-6335 fernandoprado@usp.br

Locations
Brazil
General Hospital of the University od São Paulo Medical School Recruiting
São Paulo, Brazil
Contact: Maria JC Carmona, M.D.    55-11-3069-6335    maria.carmona@incor.usp.br   
Principal Investigator: Fernando CP Silva         
Sponsors and Collaborators
Maria José Carvalho Carmona
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Maria JC Carmona, MD University of Sao Paulo Medical School
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria José Carvalho Carmona, Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01550159     History of Changes
Other Study ID Numbers: 1081/04
First Submitted: February 6, 2012
First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Maria José Carvalho Carmona, University of Sao Paulo:
Postoperative Cognitive Dysfunction
Cardiac Surgery
General Anesthesia
Neuropsychological Tests

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders