Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02979782
• Date of registration: 23/11/2016
• Prospective Registration: Yes
• Primary sponsor: Jessa Hospital
• Public title: Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft NOMICS
• Scientific title: Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft: a Single-centre Prospective Cohort Study
• Date of first enrolment: December 2016
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02979782
• Study type: Observational

Countries of recruitment

Belgium

Contacts

• Name: Björn Stessel, MD, PhD
• Affiliation: [e-mail]

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cerebrovascular Accident

Postoperative Cognitive Dysfunction

Delirium

Intervention(s)

Procedure: Endo-CABG

Procedure: PCI

Primary Outcome(s)

Prevalence of delirium [Time Frame: 3 months after intervention]

Prevalence of cerebrovascular accident [Time Frame: 3 months after intervention]

Prevalence of postoperative cognitive dysfunction [Time Frame: 3 months after intervention]

Secondary Outcome(s)

Incidence of fear after minimal invasive coronary artery bypass grafting [Time Frame: 3 months after intervention]

assessment of predictors of poor neurological outcome after minimal invasive coronary artery bypass grafting [Time Frame: 3 months after intervention]

Incidence of depression after minimal invasive coronary artery bypass grafting [Time Frame: 3 months after intervention]

Quality of life of the patient [Time Frame: 3 months after intervention]

Secondary ID(s)

16.115/anesth16.01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hasselt University