Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774342
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
I.C.C. van der Horst, University Medical Center Groningen

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?


Condition or disease Intervention/treatment
Coronary Artery Bypass Cognitive Dysfunction Procedure: Coronary Artery Bypass Grafting

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Patients undergoing coronary artery bypass grafting




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
Adult patients undergoing elective coronary artery bypass grafting
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Iwan CC van der Horst, MD, PhD +31 614698780 i.c.c.van.der.horst@umcg.nl

Locations
Layout table for location information
Netherlands
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         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Layout table for investigator information
Study Chair: Massimo A Mariani, MD, PhD University Medical Center Groningen
Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum in: Stroke. 2019 Aug;50(8):e239.
Fabrication Enterprises. Baseline LiTE Hydraulic Hand Dynamometer User Manual (1993). www.FabricationEnterprises.com

Layout table for additonal information
Responsible Party: I.C.C. van der Horst, Associate professor, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03774342    
Other Study ID Numbers: 2018226
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by I.C.C. van der Horst, University Medical Center Groningen:
Coronary artery bypass grafting
Quality of life
Cognitive dysfunction
Sarcopenia
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders