Clinical trial NCT04241289: Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients
Official title: Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients: A Cohort Evaluation Pilot (NeuroVISION Cardiac Pilot)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Silent Stroke
Cognitive Decline
Keywords: covert stroke
cognitive decline
delirium
clinical stroke
CABG surgery
near infrared spectroscopy
cerebral oxygenation
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 21 years or more scheduled to undergo isolated coronary artery bypass grafting (CABG) surgery with a median sternotomy and at least one vascular risk factor.

Brief summary: The investigators conducted a prospective observational pilot study to explore the incidence of peri-operative covert strokes (detected by brain MRI) and the potential impact on delirium and cognitive decline in post-operative cardiac surgery patients at the Hamilton General Hospital. This pilot study assessed the feasibility of a larger prospective international cohort study exploring this objective.

Detailed description: Delirium and cognitive decline are common following cardiac surgery and increase the burden on patients and health care resources. Covert (sub-clinical) strokes are associated with these complications. The investigators conducted a prospective cohort pilot study enrolling consecutive cardiac surgery patients to receive a post-operative brain MRI and a series of questionnaires to assess for changes in cognition, physical function and delirium. Regional cerebral oxygen saturation (rSO2) was recorded during surgery with the use of near-infrared spectroscopy (NIRS) sensors placed on the patients' forehead. The primary aim was to determine the feasibility of conducting a larger study to establish an association between covert stroke and long-term cognitive decline in cardiac surgery patients.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 21 years old
2. Provide written informed consent
3. Scheduled to undergo isolated CABG through a median sternotomy approach
4. Have at least one of the following risk factors:

   1. Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI \<0.9, or previous AAA repair)
   2. Cerebrovascular disease (history of stroke, TIA, or carotid stenosis \>70%)
   3. Renal insufficiency (eGFR \<60 mL/min/1.73m2)
   4. Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
   5. Urgent CABG (in-patient awaiting revascularization for ACS or MI)
   6. Recent smoker (within the last year)
   7. Left ventricular ejection fraction \<35%

Exclusion Criteria:

1. Concomitant cardiac procedure with CABG Prior enrolment in this study
2. Emergency CABG surgery (immediate revascularization for hemodynamic instability)
3. Redo CABG
4. Circulatory arrest planned during the cardiac operation
5. Diagnosed dementia of any types
6. Contra-indication for DW MRI e.g. claustrophobia, unable to lie flat for the duration of the study, pacemaker or ICD in-situ, or other metal implants

Primary outcomes:
measure: Recruitment rate
timeFrame: 30 days
measure: MRI completion
timeFrame: 30 days
measure: Lost to follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Covert stroke
timeFrame: 30 days
measure: Clinical stroke
timeFrame: 30 days
measure: Cognitive decline (MoCA)
timeFrame: 30 days
measure: Cognitive decline (DSST)
timeFrame: 30 days
measure: Physical function
timeFrame: 3 months
measure: Delirium
timeFrame: day 2 to 30 day, whichever comes first
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Andre Lamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mrkobrada M, Hill MD, Chan MT, Sigamani A, Cowan D, Kurz A, Sessler DI, Jacka M, Graham M, Dasgupta M, Dunlop V, Emery DJ, Gulka I, Guyatt G, Heels-Ansdell D, Murkin J, Pettit S, Sahlas DJ, Sharma M, Sharma M, Srinathan S, St John P, Tsai S, Gelb AW, O'Donnell M, Siu D, Chiu PW, Sharath V, George A, Devereaux PJ. Covert stroke after non-cardiac surgery: a prospective cohort study. Br J Anaesth. 2016 Aug;117(2):191-7. doi: 10.1093/bja/aew179.
citation: NeuroVISION Investigators. Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019 Sep 21;394(10203):1022-1029. doi: 10.1016/S0140-6736(19)31795-7. Epub 2019 Aug 15.
citation: Indja B, Woldendorp K, Vallely MP, Grieve SM. Silent Brain Infarcts Following Cardiac Procedures: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2019 May 7;8(9):e010920. doi: 10.1161/JAHA.118.010920.
citation: Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
citation: Newman MF, Kirchner JL, Phillips-Bute B, Gaver V, Grocott H, Jones RH, Mark DB, Reves JG, Blumenthal JA; Neurological Outcome Research Group and the Cardiothoracic Anesthesiology Research Endeavors Investigators. Longitudinal assessment of neurocognitive function after coronary-artery bypass surgery. N Engl J Med. 2001 Feb 8;344(6):395-402. doi: 10.1056/NEJM200102083440601.
citation: Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. doi: 10.1016/S1474-4422(07)70170-9.
citation: Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15.
citation: Spence J, Lamy A, Bosch J, Thabane L, Gagnon S, Power P, Browne A, Murkin J, Devereaux PJ. Feasibility of studying the association between intraoperative regional cerebral oxygen saturation and postoperative functional decline (ReFUNCTION): a pilot sub-study of NeuroVISION-Cardiac Surgery. Can J Anaesth. 2020 Nov;67(11):1497-1506. doi: 10.1007/s12630-020-01777-3. Epub 2020 Aug 6.