NCT02456493

Brief Summary

The patients who have undergone cardiac surgery have higher likelihood of postoperative cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative B-mode ultrasonography. The cognitive function measured by K-MMSE, MOCA-K before the operation, and on the 7 day, 3 months after operation. The patients in the non-surgical group are measured three times: baseline, after 7days, after 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 29, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

3.8 years

First QC Date

May 26, 2015

Last Update Submit

May 9, 2019

Conditions

Coronary Artery Occlusive Disease

Outcome Measures

Primary Outcomes (1)

  • postoperative cognitive dysfunction

    7 days after surgery

Study Arms (2)

increased carotid IMT group

Patients who have increased carotid IMT (intima media thickness)

normal carotid IMT group

Patients who have normal carotid IMT

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are schedued to undergo OPCAB

You may qualify if:

  • \- patients who are scheduled to undergo OPCAB

You may not qualify if:

  • severe cognitive dysfunction
  • disabling mental change disorder
  • unable to communicate or speak Korean
  • do not have carotid IMT measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

May 28, 2015

Study Start

June 29, 2015

Primary Completion

April 8, 2019

Study Completion

April 8, 2019

Last Updated

May 10, 2019

Record last verified: 2019-05

Locations

KR(1)