The Influence of Cognitive Decline on Quality of Life After Coronary Bypass

NCT03774342 | Unknown

• 2 other identifiers: 20182262018/226
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Coronary Artery Bypass; Cognitive Dysfunction

Keywords

Coronary artery bypass grafting; Quality of life; Cognitive dysfunction; Sarcopenia

Outcome Measures

Primary Outcomes (2)

• Change in quality of life

  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.

  at baseline (one day before surgery) and 6 months after surgery

• Change in cognitive functioning

  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.

  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.

Secondary Outcomes (2)

• Change in muscle strength

  All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.

• Change in muscle mass

  All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.

Study Arms (1)

CABG-patients

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

Interventions

Coronary Artery Bypass Grafting PROCEDURE

Patients undergoing coronary artery bypass grafting

CABG-patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective coronary artery bypass grafting

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (26)

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  BACKGROUND

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• Blokzijl F, Keus F, Houterman S, Dieperink W, van der Horst ICC, Reneman MF, Absalom AR, Mariani MA. Does postoperative cognitive decline after coronary bypass affect quality of life? Open Heart. 2021 Apr;8(1):e001569. doi: 10.1136/openhrt-2020-001569.

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MeSH Terms

Conditions

Cognitive Dysfunction; Sarcopenia

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Massimo A Mariani, MD, PhD

  University Medical Center Groningen

  STUDY CHAIR

Central Study Contacts

Iwan CC van der Horst, MD, PhD

CONTACT

+31 614698780; i.c.c.van.der.horst@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: December 12, 2018
• Study Start: October 10, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: January 11, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)