A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction (PRECISION)

A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Noncardiac Surgery

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Covert Stroke

• Study Type: Observational
• Enrollment (Actual): 934

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital
  • Beijing, China
    • Chinese People's Liberation Army General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
With stroke
Without stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of perioperative stroke	Stroke is diagnosed by MRI	Postoperative 1-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of comorbidity.	The incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.	30 days and 3 months after surgery
Postoperative cognitive function	Cognitive assessment will be conducted by trained research members who are blinded to the clinical diagnosis, treatment and MRI. The Mini-mental State Examination, Montreal cognitive assessment-basic, Mini-Mental State Examination telephone scales, Montreal Cognitive Assessment telephone scales, and Telephone Interview of Cognitive Status scale will be used to assess the cognitive function. Postoperative cognitive dysfunction is defined as at least 2 standard deviation reduction on the Mini-Mental State Examination telephone scales or Montreal Cognitive Assessment telephone scales or a Telephone Interview of Cognitive Status scale scores≤27.	1 day before surgery; and 7 days, 3 months, 1 year after surgery
Postoperative delirium	The Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) or 3 min diagnostic interview for CAM (3D-CAM) will be applied to assess 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	The Modified Rankin Scale (mRS) and Lawton instrumental activities of daily living scale (IADL) will be applied to assess the recovery quality.	1 day before surgery; and 7 days, 30 days, 3 months after surgery
The quality of life	The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.	1 day before surgery; and 7 days, 30 days, 3 months after surgery
Depression state	Depression state will be assessed with the Geriatric Depression Scale, Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9.	1 day before surgery; and 7 days, 30 days, 3 months after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Chinese PLA General Hospital

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: 2017-3-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No