NCT02941380

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Status
completed

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

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

April 29, 2016

Last Update Submit

October 20, 2016

Conditions

Ischemic Heart Disease

Keywords

coronary artery bypass graftingcardiopulmonary bypassCerebral oxidative stressCerebral inflammatory stressCerebral hemodynamicsPostoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Cerebral autoregulation

    Flow measurement of middle cerebral artery and measurement of middel arterial pressure

    6 hours post operation

Secondary Outcomes (1)

  • Postoperative cognitive function

    One day prior to operation and three days after operation

Study Arms (1)

Ischemic heart disease

Patients admitted for coronary artery bypass grafting with the use of cardiopulmonary bypass

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Cerebrovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum

MeSH Terms

Conditions

Myocardial IschemiaPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Kirsten Møller, MD PhD DMSc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 29, 2016

First Posted

October 21, 2016

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share