Exploration of Cerebral Pathophysiology During and After CABG Using CPB

Ischemic Heart Disease Clinical Trial

Official title:

Cerebral Oxidative and Inflammatory Stress and Cerebral Hemodynamics During and After Coronary Artery Bypass Grafting With Use of Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941380
• Other study ID #: H-4-2011-037
• Status: Completed
• Phase: N/A
• First received: April 29, 2016
• Last updated: October 20, 2016
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: October 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Purpose:

The purpose of this study is to examine cerebral oxidative and inflammatory stress and cerebral hemodynamics during and after coronary artery bypass grafting and correlate with postoperative cognitive function.

Description:

Postoperative cognitive decline is a well-known and well-described complication following coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but the majority of patients with postoperative cognitive decline following coronary artery bypass grafting have decline in recent and remote memory in particular.

The reason for the cognitive decline is still not fully understood though many reasons have been proposed.

Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction which may also be in combination with a reduced cerebral autoregulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with ischemic heart disease admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass

Exclusion Criteria:

• Cerebrovascular disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral autoregulation	Flow measurement of middle cerebral artery and measurement of middel arterial pressure	6 hours post operation	No
Secondary	Postoperative cognitive function		One day prior to operation and three days after operation	No