NCT03081429

Brief Summary

With the development of population aging, the incidence of covert stroke gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive outcomes. The investigators will perform a prospective cohort study. The aim of the study is to determine whether there is an association between perioperative covert stroke and postoperative cognitive outcomes in elderly patients undergoing noncardiac surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
934

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 23, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

4.3 years

First QC Date

March 10, 2017

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The incidence of perioperative stroke

    Stroke is diagnosed by MRI

    Postoperative 1-7 days

Secondary Outcomes (6)

  • Postoperative cognitive function

    1 day before surgery; and 7 days, 3 months, 1 year after surgery

  • Postoperative delirium

    twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days

  • Recovery quality

    1 day before surgery; and 7 days, 30 days, 3 months after surgery

  • The quality of life

    1 day before surgery; and 7 days, 30 days, 3 months after surgery

  • Depression state

    1 day before surgery; and 7 days, 30 days, 3 months after surgery

  • +1 more secondary outcomes

Study Arms (2)

With stroke

Without stroke

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population will be selected from patients who schedule to receive elective noncardiac surgery in Beijing Tiantan Hospital and Chinese People's Liberation Army General Hospital.

You may qualify if:

  • Eligible patients were aged ≥60 years and scheduled for elective non-cardiac surgery with general anesthesia, with or without concomitant regional analgesia. They were expected to have surgery lasting at least 2 hours of anesthesia and to stay in the hospital at least 2 days thereafter.

You may not qualify if:

  • Patients have MRI contraindications, cannot complete the cognitive evaluation, undergo carotid artery surgery or refuse to sign informed consent will be excluded from the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing TianTan Hospital

Beijing, 100070, China

Location

Chinese People's Liberation Army General Hospital

Beijing, China

Location

Related Publications (1)

  • Cui Q, Wang D, Zeng M, Dong J, Jin H, Hu Z, Zhang Y, Peng Y, Han R. Association of postoperative covert stroke and cognitive dysfunction among elderly patients undergoing non-cardiac surgery: protocol for a prospective cohort study (PRECISION study). BMJ Open. 2020 Jan 6;10(1):e034657. doi: 10.1136/bmjopen-2019-034657.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

May 23, 2018

Primary Completion

August 30, 2022

Study Completion

August 30, 2023

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations