Effect of cerebral oximetry and minimized extracorporeal circulation on cognitive dysfunction after coronary bypass in patients at high risk of cerebrovascular events

Not Applicable

• Conditions: I25.13

• Registration Number: DRKS00008853
• Lead Sponsor: niversitätsklinik für Herz- und Thoraxchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-20
• Study Completion: 2017-02-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Written authorization of the study participant
- Age> 18 years
- Coronary with or without cardiopulmonary bypass (CPB)
- Type 2 diabetes and / or renal impairment (GFR <60 ml / min)

- And / or moderate stenosis of the carotid artery of> = 35% and <70% and / or left ventricular ejection fraction of <= 35%

Exclusion Criteria

Lack of written consent
- Pregnancy
- aortic surgery
- stenosis of the carotid artery > 70%
- Documented dementia
- state after stroke
- Lack of knowledge of the German language
- Lack of possibility of follow-up studies
- Pacemakers or other electrical implants
- Claustrophobia (Ban Reason for MR subanalysis)
- Coronary (possible reason for exclusion of the MR sub-analysis). This will be decided on an individual basis according to the specifications of the stent manufacturer.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Statistically significantly lower postoperative deterioration of neurocognitive function compared with the control group<br><br>Test methods used:<br>- MoCA (Montreal Cognitive Assessment)<br>- Rey-figure / figure Taylor<br>- CVLT-k (California Verbal Learning Test - short)<br>- TMT A and B<br>- Boston Naming Test (BNT) -. Short form according Th Merten (2004)<br>- Regensburger word liquid test (RWT)<br>- Digit Span forward and backward<br>- Block span

Secondary Outcome Measures

Name	Time	Method
- Subclinical, morphological cerebrovascular events compared to baseline based MRI<br>- Intraoperative measures to improve cerebral oxygenation<br>- Duration of hospitalization<br>- Duration intensive stay<br>- Prevalence delirium<br>- Biometric data and vital signs<br>- Euro Core and Simplified Acute Physiology Score (SAPS) III<br>- Hospital mortality