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

Non-cardiac Surgery Clinical Trial

— POSIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758952
• Other study ID #: Peri-operativeStroke
• Status: Recruiting
• Start date: March 2012
• Est. completion date: March 2021

Study information

• Verified date: November 2013
• Source: Chinese Medical Association
• Contact: Yun Yue, MD
• Phone: 8610-13701275595
• Email: yueyun[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 2021
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-cardiac Surgery
• Non-neurosurgical Surgery
• Peri-operative Stroke
• Perioperative Adverse Events
• Stroke

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	No.1 Hospital of Peking University	Beijing
China	Prince of Wales Hospital	Hong Kong
China	Zhongshan Hospital, Fudan University	Shanghai
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan
China	Tangdu Hospital, The Fourth Military Medical University	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

References & Publications (1)

Ng JL, Chan MT, Gelb AW. Perioperative stroke in noncardiac, nonneurosurgical surgery. Anesthesiology. 2011 Oct;115(4):879-90. doi: 10.1097/ALN.0b013e31822e9499. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   data input system of the pilot study