Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries (POSIC)
Recruitment status was: Recruiting
Perioperative Adverse Events
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Month|
|Official Title:||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|
- perioperative stroke occurs during and within 30 days after surgery. [ Time Frame: 30 days after suegery ] [ Designated as safety issue: No ]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.
- total mortality and other major vascular complications up until 30 days after surgery [ Time Frame: 30 days after suegery ] [ Designated as safety issue: No ]
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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Beijing Chaoyang Hospital
Peking University Hospital
Zhongshan Hospital of Fudan University
Tongji Hospital, Wuhan
Tangdu Hospital, Xi'an
The Prince Welsh Hospital
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758952
|Beijing Chaoyang Hospital, Capital Medical University|
|Beijing, Beijing, China, 100013|
|No.1 Hospital of Peking University|
|Prince of Wales Hospital|
|Hong Kong, China|
|Zhongshan Hospital, Fudan University|
|Tongji Hospital, Huazhong University of Science and Technology|
|Tangdu Hospital, The Fourth Military Medical University|
|Study Chair:||Yun Yue, MD||Beijing Chao Yang Hospital|