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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01550159
• Other study ID #: 1081/04
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2012
• Last updated: March 6, 2012
• Start date: April 2009
• Est. completion date: April 2013

Study information

• Verified date: March 2012
• Source: University of Sao Paulo
• Contact: Maria JC Carmona, M.D.
• Phone: 55-11-3069-6335
• Email: maria.carmona[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
Brazil	General Hospital of the University od São Paulo Medical School	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Maria José Carvalho Carmona	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in Neuropsycological Tests	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.	1 year	Yes