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

July 15, 2020 updated by: Chinese Medical Association

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Enrolling by invitation
        • No.1 Hospital of Peking University
      • Hong Kong, China
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew Chan, M.D.
      • Shanghai, China
        • Enrolling by invitation
        • Zhongshan Hospital, Fudan University
      • Wuhan, China
        • Enrolling by invitation
        • Tongji Hospital, Huazhong University of Science and Technology
      • Xi'an, China
        • Enrolling by invitation
        • Tangdu Hospital, The Fourth Military Medical University
    • Beijing
      • Beijing, Beijing, China, 100013
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yun Yue, M.D.
        • Sub-Investigator:
          • Zhuonan Sun, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perioperative stroke occurs during and within 30 days after surgery.
Time Frame: 30 days after suegery
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
Time Frame: 30 days after suegery

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.
30 days after suegery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Medical Association

Investigators

  • Study Chair: Yun Yue, MD, Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

December 23, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peri-operativeStroke

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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