SurgeryFUNOMICSNCT05330260
Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery
An observational study of Surgery and Postoperative Cognitive Dysfunction, run by Jessa Hospital at 1 site in Belgium.
Trial summary
A monocenter observational study will be started to investigate postoperative cognitive dysfunction 5 years after minimally invasive cardiac surgery. Postoperative cognitive dysfunction will be evaluated in three groups: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Postoperative Cognitive Dysfunction
- What is being tested?
- neurocognitive test battery
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Mar 2022to 7 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects that participated in the NOMICS trail 5 years ago were invited to participate in the FUNOMICS trial.
Who may be able to join
- Minimally 18 years old
- Endo-CABG surgery 5 years ago (group 1)
- PCI surgery 5 years ago (group 2)
- Healthy volunteer 5 years ago (group 3)
Who cannot join
- Medical history of
- Stroke or POCD
- Symptomatic carotid disease
- Dementia
- Renal dysfunction (GFR < 30 ml/min)
- Hepatic dysfunction (Aspartate aminotranspferase (SGOT/AST) or Alanine Amino Transpherase (SGPT/ALT) > 3x normal limits)
Show all 13Show fewer
- History of drug, medication or alcohol abuse
- Language barrier or inability to communicate
- Physical abnormality that prevents performing the neurocognitive tests
- Surgical revision or presence of intra-operative major cardiac event (endo-CABG)
- Conversion to cardiac surgery of presence of major cardiac event (PCI)
- Simultaneous valve surgery
- Inability to travel to follow-up moment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery: Evidence for Late Cognitive Decline?
A monocenter observational study will be started to investigate postoperative cognitive dysfunction 5 years after minimally invasive cardiac surgery. Postoperative cognitive dysfunction will be evaluated in three groups: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy control group. It is hypothesized that the endo-CABG group will show a stronger postoperative cognitive dysfunction compared to the PCI group and the healthy control group.
Read the detailed description
Neurologic complications after cardiac surgery are a major cause of morbidity, prolonged hospital stay and increased costings. In selected cases, postoperative neurologic damage leads to permanent disability or decease of the patient. The American College of Cardiology and the American Heart Association classified neurological sequelae after cardiac surgery into type 1 and type 2. Type 1 morbidities are cardiovascular accident (CVA) and transient ischemic attack (TIA) whereas delirium and postoperative cognitive dysfunction (POCD) are classified as type 2 neurologic injury. Reported incidence of TIA/CVA after coronary artery bypass grafting surgery (CABG) is about 1.6-2%. Incidence of delirium and POCD is more difficult to quantify but ranges from 10-20% for delirium and 30-80% for POCD. Exact pathophysiology remains unclear but seems to be a complex interplay between macro- and microembolization, hypoperfusion and systemic inflammation. Also, preoperative neurologic state might play a role in these frequently comorbid cardiac patients. Some recent papers tried to improve neurologic outcomes by surgical, perfusionist or anesthetic adjustments, with limited success.
Literature concerning neurological complications after minimally invasive cardiac surgery (MICS) is scarce. However, this might be of special concern since in MICS, perfusion to the brain is routinely provided via retrograde flow. By consequence, the brain is possibly exposed to aortic atheroma located distal to the cerebral vessels. This is of special interest since embolic phenomena are identified as a trigger for neurologic failure after cardiac surgery. As the practice of MICS is globally expanding, observations on neurologic outcome after MICS are desirable, with screening for short-term as well as long-term complications.
An important reference article concerning late cognitive outcome after CABG surgery prospectively followed a cohort of 102 CABG patients up until five years after surgery. Patients were tested on eight neurocognitive domains at four moments in time: preoperatively, 3 months after surgery, one year after surgery and ultimately five years after surgery. Somewhat surprisingly, at follow-up on one year after surgery, patients performed significantly better at 5/8 cognitive domains without significant worse scores in the remaining domains. The authors note this finding might be attributed to the learning effect. However, on follow-up after five years, a significant decline in several domains was noted, both compared to one year follow-up as to baseline test results. Unfortunately, due to the lack of a (non-surgical) control group, the authors were unable to attribute this finding to CABG surgery itself or to the normal cognitive evolution in this aging, co-morbid population. Therefore, the group performed a nonrandomized longitudinal prospective study between conventional CABG patients, off-pump CABG (OPCAB) patients, nonsurgical coronary artery patients and healthy controls over a six-year follow-up period. They found a larger decline in all three patient groups compared to the healthy control group although none of the groups was substantially worse compared to baseline. As a result, some authors deduct postoperative neurologic decline is more dependent on preoperative patient state rather influenced by procedure-related factors. However, the influence of MICS and retrograde cardiopulmonary bypass (CPB) flow on long-term neurologic decline remains a question.
Between December 2016 and May 2018 the NOMICS trial (Neurologic Outcome after Minimally Invasive Cardiac Surgery) was performed in Jessa Hospitals, Belgium. Three groups were prospectively followed for three months: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy age and gender matched control group. A battery of neurocognitive tests was performed in all patients and control group to establish the incidence of POCD. By performing these tests again five years after baseline, the investigators will be able to screen for late cognitive decline in a MICS population undergone retrograde arterial CPB flow. Also, because of the presence of two control groups, it might be able to discriminate if the earlier established late decline is typical to the surgical population, to the coronary artery disease (CAD) population and/or normal aging effect.
- Conditions
- Surgery, Postoperative Cognitive Dysfunction
- Being tested
- neurocognitive test battery
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitive test batteryDiagnostic test
Assessment of the incidence of late postoperative cognitive decline (LPOCD)
| Study group | Role | What they receive |
|---|---|---|
| Endo-CABG | Group that underwent retrograde arterial cardiopulmonary bypass flow. Receives: Diagnostic Test: neurocognitive test battery | |
| PCI | Surgical control group Receives: Diagnostic Test: neurocognitive test battery | |
| Healthy controls | Non-surgical control group Receives: Diagnostic Test: neurocognitive test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Late postoperative cognitive dysfunction (LPOCD) at 5 years after surgery
A battery of four tests (Rey Auditory Verbal Learning Test (RAVLT), Trial Making Test (TMT A and B) and the Grooved Pegboard Test) mentioned by the 'statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery', published in 1995 supplemented with two additional tests (ie, the Welscher Adult Intelligence Scale (WAIS)-III digit span test and WAIS-III digit symbol-coding test) will be administered to determine the cognitive outcome. LPOCD is defined as an RCI (Reliable Change Index) ≤-1.645 (significance level 5%) or Z-score ≤-1.645 in at least two different tests.
Measured: through study completion, 5 year follow up after the previous study
Secondary outcomes (8)
Comparison of the evolution of LPOCD until five years after the intervention patients (both endo-CABG as PCI) versus five years after baseline for healthy volunteers
A graph will be created for the group RCI values.
Measured: through study completion, 5 year follow up after the previous study
Assessment of predictors of poor neurological outcome after Endo-CABG
The predictive value of various demographic (ie, age and gender) and perioperative variables on neurological outcome after endo-CABG will be assessed. These variables were already collected for the NOMICS trial.
Measured: through study completion, 5 year follow up after the previous study
Assessment of interim medical events: need for additional surgery
The influence of interim medical events: the need for additional or redo CABG surgery and/or PCI surgery will be assessed.
Measured: through study completion, 5 year follow up after the previous study
Quality of life questionnaire
To compare quality of life (QoL) five years after endo-CABG and PCI the European Quality of Life-5 Dimensions (EQ-5D) questionnaire will be taken. This questionnaire gives a score between 0 and 1 with 1 being the best outcome and 0 being the worst outcome.
Measured: through study completion, 5 year follow up after the previous study
Patient satisfaction
Patient satisfaction five years after endo-CABG and PCI will be assessed with an 11-point numerical rating scale (where 0= not satisfied at all and 10= extremely satisfied).
Measured: through study completion, 5 year follow up after the previous study
Interim medical events: brain trauma, dementia, or stroke
Also formally diagnosed dementia, brain trauma and/or stroke (transient ischemic attack and cerebrovascular accident) will be recorded as interim medical event.
In line with the 'statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery' a mood state assessment will be performed concurrently. Screening for depression will be performed with the Center for Epidemiological Studies Depression (CES-D) questionnaire.
Measured: through study completion, 5 year follow up after the previous study
Interim medical events: depression
In line with the 'statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery' a mood state assessment will be performed concurrently. Screening for depression will be performed with the Center for Epidemiological Studies Depression (CES-D) questionnaire.
Measured: through study completion, 5 year follow up after the previous study
Survival rate 5 years after endo-CABG and PCI
Measured: through study completion, 5 year follow up after the previous study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start25 Mar 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330260
- Sponsor's protocol ID
- f/2022/012
- Acronym
- FUNOMICS
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery: Evidence for Late Cognitive Decline?
- ClinicalTrials.gov ID
- NCT05330260
- Acronym / sponsor ID
- FUNOMICS / f/2022/012
- Conditions
- Surgery, Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A monocenter observational study will be started to investigate postoperative cognitive dysfunction 5 years after minimally invasive cardiac surgery. Postoperative cognitive dysfunction will be evaluated in three groups: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy control group. It is hypothesized that the endo-CABG group will show a stronger postoperative cognitive dysfunction compared to the PCI group and the healthy control group.
Detailed description
Neurologic complications after cardiac surgery are a major cause of morbidity, prolonged hospital stay and increased costings. In selected cases, postoperative neurologic damage leads to permanent disability or decease of the patient. The American College of Cardiology and the American Heart Association classified neurological sequelae after cardiac surgery into type 1 and type 2. Type 1 morbidities are cardiovascular accident (CVA) and transient ischemic attack (TIA) whereas delirium and postoperative cognitive dysfunction (POCD) are classified as type 2 neurologic injury. Reported incidence of TIA/CVA after coronary artery bypass grafting surgery (CABG) is about 1.6-2%. Incidence of delirium and POCD is more difficult to quantify but ranges from 10-20% for delirium and 30-80% for POCD. Exact pathophysiology remains unclear but seems to be a complex interplay between macro- and microembolization, hypoperfusion and systemic inflammation. Also, preoperative neurologic state might play a role in these frequently comorbid cardiac patients. Some recent papers tried to improve neurologic outcomes by surgical, perfusionist or anesthetic adjustments, with limited success.
Literature concerning neurological complications after minimally invasive cardiac surgery (MICS) is scarce. However, this might be of special concern since in MICS, perfusion to the brain is routinely provided via retrograde flow. By consequence, the brain is possibly exposed to aortic atheroma located distal to the cerebral vessels. This is of special interest since embolic phenomena are identified as a trigger for neurologic failure after cardiac surgery. As the practice of MICS is globally expanding, observations on neurologic outcome after MICS are desirable, with screening for short-term as well as long-term complications.
An important reference article concerning late cognitive outcome after CABG surgery prospectively followed a cohort of 102 CABG patients up until five years after surgery. Patients were tested on eight neurocognitive domains at four moments in time: preoperatively, 3 months after surgery, one year after surgery and ultimately five years after surgery. Somewhat surprisingly, at follow-up on one year after surgery, patients performed significantly better at 5/8 cognitive domains without significant worse scores in the remaining domains. The authors note this finding might be attributed to the learning effect. However, on follow-up after five years, a significant decline in several domains was noted, both compared to one year follow-up as to baseline test results. Unfortunately, due to the lack of a (non-surgical) control group, the authors were unable to attribute this finding to CABG surgery itself or to the normal cognitive evolution in this aging, co-morbid population. Therefore, the group performed a nonrandomized longitudinal prospective study between conventional CABG patients, off-pump CABG (OPCAB) patients, nonsurgical coronary artery patients and healthy controls over a six-year follow-up period. They found a larger decline in all three patient groups compared to the healthy control group although none of the groups was substantially worse compared to baseline. As a result, some authors deduct postoperative neurologic decline is more dependent on preoperative patient state rather influenced by procedure-related factors. However, the influence of MICS and retrograde cardiopulmonary bypass (CPB) flow on long-term neurologic decline remains a question.
Between December 2016 and May 2018 the NOMICS trial (Neurologic Outcome after Minimally Invasive Cardiac Surgery) was performed in Jessa Hospitals, Belgium. Three groups were prospectively followed for three months: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy age and gender matched control group. A battery of neurocognitive tests was performed in all patients and control group to establish the incidence of POCD. By performing these tests again five years after baseline, the investigators will be able to screen for late cognitive decline in a MICS population undergone retrograde arterial CPB flow. Also, because of the presence of two control groups, it might be able to discriminate if the earlier established late decline is typical to the surgical population, to the coronary artery disease (CAD) population and/or normal aging effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endo-CABG | – | Diagnostic Test: neurocognitive test batteryGroup that underwent retrograde arterial cardiopulmonary bypass flow. |
| PCI | – | Diagnostic Test: neurocognitive test batterySurgical control group |
| Healthy controls | – | Diagnostic Test: neurocognitive test batteryNon-surgical control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that participated in the NOMICS trail 5 years ago were invited to participate in the FUNOMICS trial.
Key inclusion criteria (4 listed)
- Minimally 18 years old
- Endo-CABG surgery 5 years ago (group 1)
- PCI surgery 5 years ago (group 2)
- Healthy volunteer 5 years ago (group 3)
Key exclusion criteria (13 listed)
- Medical history of
- History of drug, medication or alcohol abuse
- Language barrier or inability to communicate
- Physical abnormality that prevents performing the neurocognitive tests
- Surgical revision or presence of intra-operative major cardiac event (endo-CABG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurocognitive test batteryAssessment of the incidence of late postoperative cognitive decline (LPOCD) | Diagnostic test | Endo-CABG, Healthy controls, PCI |
Primary outcome
The incidence of Late postoperative cognitive dysfunction (LPOCD) at 5 years after surgery
Time frame: through study completion, 5 year follow up after the previous study
A battery of four tests (Rey Auditory Verbal Learning Test (RAVLT), Trial Making Test (TMT A and B) and the Grooved Pegboard Test) mentioned by the 'statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery', published in 1995 supplemented with two additional tests (ie, the Welscher Adult Intelligence Scale (WAIS)-III digit span test and WAIS-III digit symbol-coding test) will be administered to determine the cognitive outcome. LPOCD is defined as an RCI (Reliable Change Index) ≤-1.645 (significance level 5%) or Z-score ≤-1.645 in at least two different tests.
8 secondary outcomes
Comparison of the evolution of LPOCD until five years after the intervention patients (both endo-CABG as PCI) versus five years after baseline for healthy volunteers
Time frame: through study completion, 5 year follow up after the previous study
Assessment of predictors of poor neurological outcome after Endo-CABG
Time frame: through study completion, 5 year follow up after the previous study
Assessment of interim medical events: need for additional surgery
Time frame: through study completion, 5 year follow up after the previous study
Quality of life questionnaire
Time frame: through study completion, 5 year follow up after the previous study
Patient satisfaction
Time frame: through study completion, 5 year follow up after the previous study
Interim medical events: brain trauma, dementia, or stroke
Time frame: through study completion, 5 year follow up after the previous study
Interim medical events: depression
Time frame: through study completion, 5 year follow up after the previous study
Survival rate 5 years after endo-CABG and PCI
Time frame: through study completion, 5 year follow up after the previous study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Postoperative Cognitive Dysfunction, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Late postoperative cognitive dysfunction (LPOCD) at 5 years after surgery (time frame: through study completion, 5 year follow up after the previous study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.