Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries

Study Overview
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Brief Summary
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Stroke is an important cause of perioperative morbidity and mortality, particularly in patients > 60 years. In cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). However, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. We therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.

Detailed Description
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Patient population: Prospective cohort study of 10,000 adults undergoing non-cardiac, non-neurological surgery. Screening and enrollment: Consecutive patients undergoing (elective or emergency) non-cardiac, non-neurosurgical surgeries will be recruited. Monitoring, follow-up, and data collection: Usual treatment will be provided. Demographic details will be recorded. Patients will be visited regularly in hospital. Patient will be reviewed for neurologic deficit using the mNIHSS. Brain imaging will be performed to confirm stroke event. Follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.

Official Title
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Multi-center Prospective Investigation of Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries and Practicability of NIHSS in Screening Peri-operative Strokes

Conditions
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Peri-operative Stroke, Perioperative Adverse Events, Non-cardiac Surgery, Non-neurosurgical Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages Eligible for Study: 60 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Sampling Method: Probability Sample Exclusion Criteria: hospital stay after surgery less than 3 days not consent of the assessment surgery canceled

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Beijing Chaoyang Hospital<br>2000 cases | |
| Peking University Hospital<br>2000 cases | |
| Zhongshan Hospital of Fudan University<br>2000 cases | |
| Tongji Hospital, Wuhan<br>2000 cases | |
| Tangdu Hospital, Xi'an<br>2000 cases | |
| The Prince Welsh Hospital<br>1000 cases | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative stroke occurs during and within 30 days after surgery. | The primary outcome is perioperative stroke occurs during and within 30 days after surgery. This is defined as cerebral infarction or hemorrhage on computer tomography or magnetic resonance scan, or new neurological signs (paralysis, weakness or speech difficulties) lasting more than 24 hours or leading to death. The mechanism of stroke will be classified using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. | 30 days after suegery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total mortality and other major vascular complications up until 30 days after surgery | Secondary outcomes include total mortality and other major vascular complications up until 30 days after surgery: Myocardial infarction is defined according to recent universal definition of myocardial infarction; Nonfatal cardiac arrest is a successful resuscitation from either documented or presumed ventricular fibrillation or sustained ventricular tachycardia or asystole; Pulmonary embolism; Congestive heart failure is defined by both clinical and radiographic evidence; Clinically significant atrial fibrillation is defined as atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; Cardiac death: defined as any death with a cardiovascular cause, including deaths following a cardiovascular procedure, cardiac arrest, myocardial infarction, pulmonary embolus, stroke, hemorrhage, or deaths due to unknown cause. | 30 days after suegery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-operative stroke, incidence, risk factors, prospective