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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04241289
Other study ID # NeuroVISION Cardiac Pilot
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 27, 2017
Est. completion date September 30, 2018

Study information

Verified date March 2023
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 30, 2018
Est. primary completion date June 25, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Hamilton General Hospital Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Erratum In: N Engl J Med 2001 Jun 14;344(24):1876. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rate Average recruitment rate per week 30 days
Primary MRI completion Total number of patients completing the brain MRI study 30 days
Primary Lost to follow-up Proportion of patients lost to follow-up at the end of the study 3 months
Secondary Covert stroke The proportion of patients experiencing covert stroke within 30 days of surgery 30 days
Secondary Clinical stroke The proportion of patients experiencing clinical stroke 30 days after surgery 30 days
Secondary Cognitive decline (MoCA) The proportion of patients experiencing cognitive decline 30 days after surgery using the Montreal Cognitive Assessment (MoCA). 30 days
Secondary Cognitive decline (DSST) The proportion of patients experiencing cognitive decline 30 days after surgery using the Digit Symbol Substitution Test (DSST). 30 days
Secondary Physical function The proportion of patients experiencing cognitive decline 30 days after surgery using the Standard Assessment of Global-activities in the Elderly (SAGE). 3 months
Secondary Delirium The proportion of patients experiencing delirium between postoperative day 2 and discharge or 30 days, whichever comes first using the Confusion Assessment Method (CAM). day 2 to 30 day, whichever comes first
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