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NCT02456493 Clinical Trial

The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery

Coronary Artery Occlusive Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02456493
Other study ID # 4-2015-0254
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2015
Est. completion date April 8, 2019

Study information
Verified date May 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date April 8, 2019
Est. primary completion date April 8, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- patients who are scheduled to undergo OPCAB

Exclusion Criteria:

- severe cognitive dysfunction

- disabling mental change disorder

- unable to communicate or speak Korean

- do not have carotid IMT measurement.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative cognitive dysfunction 7 days after surgery
See also
  Status Clinical Trial Phase
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Recruiting NCT04598191 - Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery N/A
Completed NCT01067638 - The Effect of Tranexamic Acid on Postoperative Blood Loss and Coagulation in Patients With Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; Double Blind Randomized Control Study Phase 4
Completed NCT01051206 - The Effect of 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients Medicated With Antiplatelet Agents Prior to Off-Pump Coronary Bypass Graft Surgery Phase 4
Completed NCT01872845 - A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT N/A
Completed NCT02206412 - Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Off-pump Coronary Artery Bypass Graft
Completed NCT01084044 - Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery Phase 4
Completed NCT04654663 - Impact of Sarcopenia Index on Postoperative Pulmonary Complication in Elderly Patients Undergoing OPCAB
Completed NCT01836081 - Respirophasic Carotid Artery Peak Velocity Variation as a Predictor of Fluid Responsiveness in Patients With Coronary Disease N/A