Peri-operative StrokePOSICNCT01758952
Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries
An observational study of Peri-operative Stroke and Perioperative Adverse Events, run by Chinese Medical Association at 6 sites in China.
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%). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Peri-operative Stroke, Perioperative Adverse Events, Non-cardiac Surgery
- How many people
- 10,000 participants
- Where
- 6 sitesChina
- Study dates
- Mar 2012to Mar 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%.
Who may be able to join
- Ages Eligible for Study: 60 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Sampling Method: Probability Sample
Who cannot join
- hospital stay after surgery less than 3 days
- not consent of the assessment
- surgery canceled
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100013
Yun Yue, MD, 8610-13701275595, yueyun@hotmail.com
Zhuonan Sun, MD, 8610-18701052470, szn19_lucky5566@163.com
- Enrolling by invitation
No.1 Hospital of Peking University
Beijing
- Recruiting
Prince of Wales Hospital
Hong Kong
Matthew Chan, M.D., 852-263-22894 ext. 2736, mtvchan@cuhk.edu.hk
Keung Tat Lee, 852-2632-6067, ktlee@cuhk.edu.hk
- Enrolling by invitation
Zhongshan Hospital, Fudan University
Shanghai
- Enrolling by invitation
Tongji Hospital, Huazhong University of Science and Technology
Wuhan
- Enrolling by invitation
Tangdu Hospital, The Fourth Military Medical University
Xi'an
About this study
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
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.
Read the 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.
- Conditions
- Peri-operative Stroke, Perioperative Adverse Events, Non-cardiac Surgery, Non-neurosurgical Surgery
- Keywords
- Peri-operative stroke, incidence, risk factors, prospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after suegery
Secondary outcomes (1)
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.
Measured: 30 days after suegery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-operative StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yun Yue, MD, Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758952
- Sponsor's protocol ID
- Peri-operativeStroke
- Acronym
- POSIC
- Status last verified
- Nov 2013
- First submitted
- 23 Dec 2012
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ng JL, Chan MT, Gelb AW. Perioperative stroke in noncardiac, nonneurosurgical surgery. Anesthesiology. 2011 Oct;115(4):879-90. doi: 10.1097/ALN.0b013e31822e9499.
PubMed 21862923
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01758952
- Acronym / sponsor ID
- POSIC / Peri-operativeStroke
- Conditions
- Peri-operative Stroke, Perioperative Adverse Events, Non-cardiac Surgery, Non-neurosurgical Surgery
- Keywords
- Peri-operative stroke, incidence, risk factors, prospective
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%.
Key inclusion criteria (4 listed)
- Ages Eligible for Study: 60 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Sampling Method: Probability Sample
Key exclusion criteria (3 listed)
- hospital stay after surgery less than 3 days
- not consent of the assessment
- surgery canceled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
total mortality and other major vascular complications up until 30 days after surgery
Time frame: 30 days after suegery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 21862923Ng JL, Chan MT, Gelb AW. Perioperative stroke in noncardiac, nonneurosurgical surgery. Anesthesiology. 2011 Oct;115(4):879-90. doi: 10.1097/ALN.0b013e31822e9499.
- data input system of the pilot studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Yue, MD study chair
Beijing Chao Yang Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-operative Stroke and Perioperative Adverse Events, run by Chinese Medical Association at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Yue, MD (8610-13701275595, yueyun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative stroke occurs during and within 30 days after surgery. (time frame: 30 days after suegery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.