Coronary Artery Occlusive DiseaseNCT02456493
The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery
An observational study of Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Occlusive Disease
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2015to 8 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are schedued to undergo OPCAB
Who may be able to join
- patients who are scheduled to undergo OPCAB
Who cannot join
- severe cognitive dysfunction
- disabling mental change disorder
- unable to communicate or speak Korean
- do not have carotid IMT measurement.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
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.
- Conditions
- Coronary Artery Occlusive Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| increased carotid IMT group | Patients who have increased carotid IMT (intima media thickness) | |
| normal carotid IMT group | Patients who have normal carotid IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cognitive dysfunction
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study start29 Jun 2015
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456493
- Sponsor's protocol ID
- 4-2015-0254
- Status last verified
- May 2019
- First submitted
- 26 May 2015
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT02456493
- Acronym / sponsor ID
- 4-2015-0254
- Conditions
- Coronary Artery Occlusive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| increased carotid IMT group | – | –Patients who have increased carotid IMT (intima media thickness) |
| normal carotid IMT group | – | –Patients who have normal carotid IMT |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are schedued to undergo OPCAB
Key inclusion criteria (1 listed)
- patients who are scheduled to undergo OPCAB
Key exclusion criteria (4 listed)
- severe cognitive dysfunction
- disabling mental change disorder
- unable to communicate or speak Korean
- do not have carotid IMT measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative cognitive dysfunction
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cognitive dysfunction (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.