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Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft (NOMICS)

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ClinicalTrials.gov Identifier: NCT02979782
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : December 14, 2018
Sponsor:
Collaborator:
Hasselt University
Information provided by (Responsible Party):
Stessel Björn, Jessa Hospital

Brief Summary:

Primary objectives:

Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular accident (CVA), and delirium after minimal invasive coronary artery bypass grafting (Endo-CABG).

Secondary objectives:

  • Quality of life, three months after endo-CABG
  • Patient satisfaction with endo-CABG and the tests performed
  • The influence of various demographic and peri-operative variables on neurological outcome after endo-CABG
  • Incidence of fear and depression, 3 months after endo-CABG

Condition or disease Intervention/treatment
Postoperative Cognitive Dysfunction Cerebrovascular Accident Delirium Procedure: Endo-CABG Procedure: PCI

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft: a Single-centre Prospective Cohort Study
Actual Study Start Date : December 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Endo-CABG, surgical group
the minimal invasive cardiac surgery group
Procedure: Endo-CABG
minimal invasive cardiac intervention
Other Name: minimal invasive Coronary Artery Bypass Grafting

PCI, comparative surgical group
a comparative minimal invasive procedure
Procedure: PCI
stenting procedure
Other Name: percutaneous coronary intervention

Healthy volunteer, control group
to exclude any learning effect or natural variation in neurological testing



Primary Outcome Measures :
  1. Prevalence of postoperative cognitive dysfunction [ Time Frame: 3 months after intervention ]
    percentage of total study population

  2. Prevalence of delirium [ Time Frame: 3 months after intervention ]
    percentage of total study population

  3. Prevalence of cerebrovascular accident [ Time Frame: 3 months after intervention ]
    percentage of total study population


Secondary Outcome Measures :
  1. Quality of life of the patient [ Time Frame: 3 months after intervention ]
    assessment with the EQ-5D questionnaire

  2. assessment of predictors of poor neurological outcome after minimal invasive coronary artery bypass grafting [ Time Frame: 3 months after intervention ]
    assessment of which demographic and peri-operative variables are associated with poor neurological outcome after minimal invasive coronary

  3. Incidence of depression after minimal invasive coronary artery bypass grafting [ Time Frame: 3 months after intervention ]
    assessment with the CES-D questionnaire

  4. Incidence of fear after minimal invasive coronary artery bypass grafting [ Time Frame: 3 months after intervention ]
    assessment with the Surgical Fear Questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The population will be divided into three groups. The first group will be the Endo-CABG group which consist of the patients who undergo minimal invasive coronary artery bypass grafting.

The second group consists of patients who will get an elective PCI intervention. this is a comparative group which is included to check whether the assessed prevalences in the Endo-CABG group are not related to underlying cardiac anomalies or to other cardiac intervention procedures.

The third group consists of healthy volunteers. This control group will be included to eliminate natural variation in neurophysiological testing and to exclude the learning effect which can occur when repeated neurophysiological testing is performed.

Criteria

Inclusion Criteria:

  • Minimum age of 18
  • Elective Endo-CABG procedure (group 1)
  • Elective PCI procedure (group 2)
  • Elective healthy volunteer

Exclusion Criteria:

  • Medical history of:
  • Postoperative cognitive dysfunction, delirium or cerebrovascular accident
  • symptomatic carotid artery disease
  • Dementia
  • Renal dysfunction: glomular filtration rate (GFR) < 30 ml/min
  • Hepatic dysfunction: serum glutamic-oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST), or serum glutamic-pyruvic transaminase (SGPT)/ alanine aminotransferase (ALT), more than three timer higher than normal limits
  • History of medication and alcohol abuse
  • Language barrier or incapability to communicate
  • Physical condition making participation impossible
  • Participation in other clinical trials of a drug or medical instrument
  • Surgical revision or intra-operative major cardial event (Endo-CABG group)
  • Conversion to cardiac surgery or intra-operative major event (PCI group)

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): NCT02979782


Locations
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Belgium
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Jessaziekenhuis Hasselt
Hasselt, Limburg, Belgium, 3500
Sponsors and Collaborators
Jessa Hospital
Hasselt University
Investigators
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Principal Investigator: Björn Stessel, MD, PhD bjornstessel@hotmail.com

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stessel Björn, MD, Jessa Hospital
ClinicalTrials.gov Identifier: NCT02979782     History of Changes
Other Study ID Numbers: 16.115/anesth16.01
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Stessel Björn, Jessa Hospital:
cardiac surgery
neurological outcome
minimal invasive coronary artery bypass graft (Endo-CABG)
Additional relevant MeSH terms:
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Delirium
Stroke
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases