NCT01550159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

3.8 years

First QC Date

February 6, 2012

Last Update Submit

March 6, 2012

Conditions

Keywords

Postoperative Cognitive DysfunctionCardiac SurgeryGeneral AnesthesiaNeuropsychological Tests

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients underwent for coronary artery bypass graft surgery.

You may qualify if:

  • Patients underwent for coronary artery bypass graft surgery

You may not qualify if:

  • History of brain disease or dementia, other psychiatric disorders that affect cognition
  • Lack of proficiency in Portuguese language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of the University od São Paulo Medical School

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Maria JC Carmona, MD

    University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria JC Carmona, M.D.

CONTACT

Fernando CP Silva

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery

Study Record Dates

First Submitted

February 6, 2012

First Posted

March 9, 2012

Study Start

April 1, 2009

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations