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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT01550159
First received: February 6, 2012
Last updated: March 6, 2012
Last verified: March 2012
  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 University of Sao Paulo:

Primary Outcome Measures:
  • Score in Neuropsycological Tests [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 6, 2012
Last Updated: March 6, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Postoperative Cognitive Dysfunction
Cardiac Surgery
General Anesthesia
Neuropsychological Tests

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014