NCT04241289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

January 22, 2020

Last Update Submit

March 24, 2023

Conditions

Silent StrokeCognitive Decline

Keywords

covert strokecognitive declinedeliriumclinical strokeCABG surgerynear infrared spectroscopycerebral oxygenation

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Average recruitment rate per week

    30 days

  • MRI completion

    Total number of patients completing the brain MRI study

    30 days

  • Lost to follow-up

    Proportion of patients lost to follow-up at the end of the study

    3 months

Secondary Outcomes (6)

  • Covert stroke

    30 days

  • Clinical stroke

    30 days

  • Cognitive decline (MoCA)

    30 days

  • Cognitive decline (DSST)

    30 days

  • Physical function

    3 months

  • +1 more secondary outcomes

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Male or female ≥ 21 years old
  • Provide written informed consent
  • Scheduled to undergo isolated CABG through a median sternotomy approach
  • Have at least one of the following risk factors:
  • Peripheral vascular disease (previous peripheral arterial bypass, amputation due to ischemia, ABPI \<0.9, or previous AAA repair)
  • Cerebrovascular disease (history of stroke, TIA, or carotid stenosis \>70%)
  • Renal insufficiency (eGFR \<60 mL/min/1.73m2)
  • Diabetes mellitus (on oral hypoglycemic agent(s) and/or insulin replacement)
  • Urgent CABG (in-patient awaiting revascularization for ACS or MI)
  • Recent smoker (within the last year)
  • Left ventricular ejection fraction \<35%

You may not qualify if:

  • Concomitant cardiac procedure with CABG Prior enrolment in this study
  • Emergency CABG surgery (immediate revascularization for hemodynamic instability)
  • Redo CABG
  • Circulatory arrest planned during the cardiac operation
  • Diagnosed dementia of any types
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (8)

  • 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.

    PMID: 27440630BACKGROUND

  • 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.

    PMID: 31422895BACKGROUND

  • 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.

    PMID: 31017035BACKGROUND

  • 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.

    PMID: 22762316BACKGROUND

  • 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.

    PMID: 11172175BACKGROUND

  • 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.

    PMID: 17582361BACKGROUND

  • 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.

    PMID: 27980126BACKGROUND

  • 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.

    PMID: 32767054DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDelirium

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andre Lamy, MD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

March 27, 2017

Primary Completion

June 25, 2018

Study Completion

September 30, 2018

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)