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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chinese Medical Association
Sponsor:
Information provided by (Responsible Party):
Chinese Medical Association
ClinicalTrials.gov Identifier:
NCT01758952
First received: December 23, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


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

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

Further study details as provided by Chinese Medical Association:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

    1. Myocardial infarction is defined according to recent universal definition of myocardial infarction;
    2. Nonfatal cardiac arrest is a successful resuscitation from either documented or presumed ventricular fibrillation or sustained ventricular tachycardia or asystole;
    3. Pulmonary embolism;
    4. Congestive heart failure is defined by both clinical and radiographic evidence;
    5. 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;
    6. 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

whole blood, serum, white cells


Estimated Enrollment: 10000
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)
Groups/Cohorts
Beijing Chaoyang Hospital
2000 cases
Peking University Hospital
2000 cases
Zhongshan Hospital of Fudan University
2000 cases
Tongji Hospital, Wuhan
2000 cases
Tangdu Hospital, Xi'an
2000 cases
The Prince Welsh Hospital
1000 cases

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We propose a sample size of 10,000 patients to ensure a stable logistic model for an anticipated stroke rate of 1.0%.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758952

Contacts
Contact: Yun Yue, MD 8610-13701275595 yueyun@hotmail.com
Contact: Zhuonan Sun, MD 8610-18701052470 szn19_lucky5566@163.com

Locations
China, Beijing
Beijing Chaoyang Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100013
Contact: Yun Yue, MD    8610-13701275595    yueyun@hotmail.com   
Contact: Zhuonan Sun, MD    8610-18701052470    szn19_lucky5566@163.com   
Principal Investigator: Yun Yue, M.D.         
Sub-Investigator: Zhuonan Sun, M.D.         
China
No.1 Hospital of Peking University Enrolling by invitation
Beijing, China
Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Matthew Chan, M.D.    852-263-22894 ext 2736    mtvchan@cuhk.edu.hk   
Contact: Keung Tat Lee    852-2632-6067    ktlee@cuhk.edu.hk   
Principal Investigator: Matthew Chan, M.D.         
Zhongshan Hospital, Fudan University Enrolling by invitation
Shanghai, China
Tongji Hospital, Huazhong University of Science and Technology Enrolling by invitation
Wuhan, China
Tangdu Hospital, The Fourth Military Medical University Enrolling by invitation
Xi'an, China
Sponsors and Collaborators
Chinese Medical Association
Investigators
Study Chair: Yun Yue, MD Beijing Chaoyang Hospital, Capital Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Chinese Medical Association
ClinicalTrials.gov Identifier: NCT01758952     History of Changes
Other Study ID Numbers: Peri-operativeStroke
Study First Received: December 23, 2012
Last Updated: November 6, 2013
Health Authority: China: Ministry of Health

Keywords provided by Chinese Medical Association:
Peri-operative stroke
incidence
risk factors
prospective

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 19, 2014