Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN (NeuroVISION)
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| ClinicalTrials.gov Identifier: NCT01980511 |
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Recruitment Status :
Completed
First Posted : November 11, 2013
Last Update Posted : January 10, 2019
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Sponsor:
McMaster University
Collaborators:
Hamilton Health Sciences Corporation
Health and Medical Research Fund
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Information provided by (Responsible Party):
McMaster University
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Brief Summary:
The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute covert stroke using an MRI study of the brain in the days following noncardiac surgery. We will characterize the epidemiology and the impact of covert stroke in patients undergoing noncardiac surgery, and its association with cerebral deoxygenation.
| Condition or disease |
|---|
| Covert Postoperative Stroke |
At the University of Wisconsin a planned sub study of NeuroVISION is being conducted aiming to enroll 100 patients with additional cognitive testing, MRI sequences and a preoperative MRI scan.
At Hamilton Juravinski Hospital, Hamilton General Hospital, Auckland City Hospital and Prince of Wales Hospital a planned sub study of NeuroVISION (PAFS - Perioperative Atrial Fibrillation and Postoperative Stroke) is being conducted aiming to enroll 400 participants. The purpose of this sub-study is to determine the prevalence of AF(Atrial Fibrillation) before surgery (i.e. "background" AF), as well of the incidence of AF after surgery using the Icentia CardioSTAT "patch-like" single lead heart rhythm monitor.
| Study Type : | Observational |
| Actual Enrollment : | 1116 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN |
| Actual Study Start Date : | March 24, 2014 |
| Actual Primary Completion Date : | October 11, 2018 |
| Actual Study Completion Date : | November 6, 2018 |
Primary Outcome Measures :
- Postoperative cognitive dysfunction [ Time Frame: 1 year ]Our primary objective is to characterize the impact of postoperative covert stroke on neurocognitive function 1 year after elective noncardiac surgery, as measured by a decrease of two or more points on the Montreal Cognitive Assessment (MoCA) scale from preoperative baseline test to the 1-year follow-up.
Secondary Outcome Measures :
- Incidence of acute postoperative covert stroke [ Time Frame: 30 days ]We will detect acute postoperative covert stroke using an MR study of the brain that will be performed between postoperative days 2 and 9.
- Clinical 30-day outcomes (rated yes/no) [ Time Frame: 30 days ]Overt stroke, transient ischemic attack, death, myocardial infarction, myocardial injury after noncardiac surgery, nonfatal cardiac arrest, major adverse cardiovascular events, cardiac revascularization procedures, bleeding, new atrial fibrillation, hypotension, congestive heart failure, new acute renal failure, infection and sepsis
- Clinical 1-year outcomes (rated yes/no) [ Time Frame: 1 year ]Overt stroke, transient ischemic attack, death, myocardial infarction, nonfatal cardiac arrest, major adverse cardiovascular events (composite), congestive heart failure, new acute renal failure, dementia and mild cognitive impairment
- Postoperative delirium [ Time Frame: 30 days ]Delirium will be measured using the Cognitive Assessment Method (CAM).
- Physical function after surgery as assessed using the Modified Rankin Scale [ Time Frame: 30 days and 1 year ]Physical function will be measured using the Modified Rankin Scale. The Modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people. The scale runs from 0-6, running from perfect health without symptoms to death. A higher score is worse.
- Physical function after surgery as assessed using the Lawton Instrumental Activities of Daily Living (iADL) Scale [ Time Frame: 30 days and 1 year ]Physical function will be measured using the Lawton Instrumental Activities of Daily Living (iADL) Scale. The Lawton Instrumental Activities of Daily Living Scale refers to people's daily self-care activities. It consists of 8 activities. A lower score is worse.
- Quality of life after surgery [ Time Frame: 30 days and 1 year ]We will use the EQ-5D questionnaire to assess the patients' health-related quality of life. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The first part contains the EQ-5D descriptive system, comprising of 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A higher score is worse. The second part is a vertical, visual analogue scale with the end-points of "best imaginable health state" and "worst imaginable health state". Scale runs from 0 to 100. A lower score is worse.
- Depressive symptoms after surgery [ Time Frame: 30 days and 1 year ]We will use the 5-question version of the Geriatric Depression Scale (GDS-5) to measure depressive symptoms. The 5-question version of the Geriatric Depression Scale scoring will be from 0 to 5. The higher values indicate increasing depressive symptoms.
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients undergoing elective non-cardiac surgery, ≥ 65 years old and an anticipated hospital stay of at least 2 days after elective noncardiac surgery that occurs under general or neuraxial anesthesia.
Criteria
Inclusion Criteria:
- Age ≥65 years old
- An anticipated hospital stay of at least 2 days after elective noncardiac surgery that occurs under general or neuraxial anesthesia
- Written informed consent for potential participation prior to noncardiac surgery
Exclusion Criteria:
- Contraindication to MRI (e.g. implanted devices not safe for MRI studies, claustrophobia)
- Unable or unwilling to attend the follow-up appointments
- Documented history of dementia
- Residing in a nursing home
- Undergoing carotid artery surgery or intracranial surgery
- Unable to complete neurocognitive testing due to language, vision or hearing impairment
- Unable to communicate with the research staff due to language barriers
- Patients who do not undergo their research MRI study after surgery
- Patients who do not complete a baseline MoCA questionnaire
- Patients who suffer an acute overt clinical stroke after the index surgery, but before their research MR study
- Previously enrolled in the NeuroVISION Study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980511
Locations
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53706 | |
| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Ontario | |
| Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| University Hospital, London Health Sciences | |
| London, Ontario, Canada, N6A 5A5 | |
| Chile | |
| Clinica Santa Maria | |
| Providencia, Santiago, Chile, 7520378 | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Shatin, SAR, Hong Kong | |
| India | |
| Narayana Health | |
| Bangalore, India | |
| Malaysia | |
| University Malaya Medical Centre | |
| Kuala Lumpur, Malaysia, 59100 | |
| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1023 | |
| Peru | |
| Hospital Cayetano Heredia | |
| Lima, Peru, Lima31 | |
| Poland | |
| Szpital Specjalistycznym | |
| Krakow, Poland | |
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Health and Medical Research Fund
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Investigators
| Principal Investigator: | P.J. Devereaux, MD, PhD | Population Health Research Institute | |
| Principal Investigator: | Marko Mrkobrada, MD, FRCPC | University of Western Ontario, Canada |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT01980511 |
| Other Study ID Numbers: |
NeuroVISION v4.0 |
| First Posted: | November 11, 2013 Key Record Dates |
| Last Update Posted: | January 10, 2019 |
| Last Verified: | January 2019 |