The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
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|ClinicalTrials.gov Identifier: NCT03774342|
Recruitment Status : Unknown
Verified December 2018 by I.C.C. van der Horst, University Medical Center Groningen.
Recruitment status was: Recruiting
First Posted : December 12, 2018
Last Update Posted : January 11, 2019
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During the last decades improvements in operative techniques and perioperative care have led to a steady decline in mortality after cardiac surgery. Good survival rates have been shown repeatedly although elderly patients have an increased risk for prolonged hospital stay and postoperative complications such as neurological and pulmonary problems. Post-operative cognitive decline (POCD) is common after cardiac surgery and although this cognitive decline can be subtle, in elderly vulnerable patients even a small decline can have important consequences such as a decreased quality of life and loss of independence. Recent studies among patients after coronary artery bypass grafting (CABG) found that the incidence of POCD varied between 30-60% depending on cognitive tests, time of assessment and patient populations.
Cognitive and physical impairment frequently co-occur in older people. The association between cognitive impairment and functional disability has been investigated in several studies, which demonstrated that cognitive decline is associated with functional disability, also after cardiac surgery. One method for estimation of patients' physical performance is to evaluate sarcopenia. Sarcopenia is defined as a syndrome characterised by progressive and generalised loss of skeletal muscle mass and strength, leading to an increased risk of adverse outcomes such as physical disability, poor quality of life and death. Data on the prevalence of sarcopenia in community-dwelling residents or nursing-homes are widely available, but little is known on (elderly) hospitalized patients after cardiac surgery. The aim of this study is to evaluate the association between post-operative cognitive decline, quality of life (QoL) and sarcopenia in adult patients after coronary artery bypass grafting. The investigators hypothesize that a decreased postoperative QoL is mainly explained by POCD, therefore the primary research question of this study is: What is the influence of post-operative cognitive decline on QoL after CABG? The secondary research question is: Is there an association between postoperative sarcopenia and a decreased postoperative QoL?
|Condition or disease||Intervention/treatment|
|Coronary Artery Bypass Cognitive Dysfunction||Procedure: Coronary Artery Bypass Grafting|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||The Influence of Cognitive Decline on Quality of Life After Coronary Bypass|
|Actual Study Start Date :||October 10, 2018|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
We will study one group of patients all scheduled for a Coronary Artery Bypass Grafting-procedure. This observational study consists of one group.
Procedure: Coronary Artery Bypass Grafting
Patients undergoing coronary artery bypass grafting
- Change in quality of life [ Time Frame: at baseline (one day before surgery) and 6 months after surgery ]Quality of life will be assessed using the RAND-36 version 2 questionnaire, a widely validated questionnaire including eight health domains; physical functioning, social functioning, role limitations due to physical health problems, role limitations due to emotional problems, mental health, vitality, pain and general health perception. Outcomes at each domain will be defined on a scale from a minimum score of 0 to a maximum score of 100. A higher score is equivalent to a better health.
- Change in cognitive functioning [ Time Frame: Two sets of cognitive tests will be performed on the day before surgery; one practice test and a second test that will be used as a baseline test. Follow-up tests will be performed at 3 days and 6 months after surgery. ]Cognitive function will be assessed using a set of computerised cognitive tests.This set of tests consists of the detection task, the identification task, the one card learning task and the one back task assessing psychomotor speed, selective attention, visual learning and working memory, respectively.
- Change in muscle strength [ Time Frame: All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery. ]Assessment of handgrip strength using the Baseline LiTE Hydraulic Hand Dynamometer will be assessed for estimation of muscle function. To become familiar with the test, patients will be allowed to perform one practice-test, and then three consecutive tests will be carried out with one minute rest between tests. Only the highest score of the handgrip test will be used for analysis; strength is measured in kilograms and the testresults will be compared with the reference values recommended by the EWGSOP guidelines.
- Change in muscle mass [ Time Frame: All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery. ]Bioelectrical impedance analysis (BIA) will be used for estimation of muscle mass. For the calculation of muscle mass the measurements Resistance, Reactance and Phase Angle will be obtained with BIA. These values will be computed by empirically formulated equations based on healthy people leading to values for muscle mass, body cell mass, fat mass and fat free mass. Cut-off values based on normative populations of men and women and recommended by the sarcopenia work group (EWGSOP) will be used as reference for the study population.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- adult patients scheduled for elective, isolated on-pump CABG
- able to stand and walk independently
- able to participate in the online screenings module for cognitive function to reduce the amount of missing data for cognitive function
- Pre-existing neurological deficits
- Psychiatric illness
- previous cardiac surgery
- pre-existing muscular diseases or missing extremities
- presence of an Internal Cardioverter Defibrillator (ICD), assist device or pacemaker
- large amounts of metal in or around the body
- inability to read or understand Dutch instructions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774342
|Contact: Iwan CC van der Horst, MD, PhD||+31 email@example.com|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9700 RB|
|Sub-Investigator: Fredrike Blokzijl, MSc|
|Sub-Investigator: Willem Dieperink, PhD|
|Sub-Investigator: Frederik Keus, MD, PhD|
|Sub-Investigator: Michiel F Reneman, PhD|
|Study Chair:||Massimo A Mariani, MD, PhD||University Medical Center Groningen|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||I.C.C. van der Horst, Associate professor, University Medical Center Groningen|
|Other Study ID Numbers:||
2018/226 ( Other Identifier: METc - University Medical Center Groningen )
|First Posted:||December 12, 2018 Key Record Dates|
|Last Update Posted:||January 11, 2019|
|Last Verified:||December 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Coronary artery bypass grafting
Quality of life