NCT05333146

Brief Summary

Perioperative stroke is a devastating complication of cardiac surgery that is currently poorly characterized but occurs in 1-5% of patients and is associated with poor outcomes including increased mortality. Given the uncommon nature of this complication, relatively little is known about which factors predict these outcomes among those who experience a perioperative stroke. The study objectives are to identify predictors of mortality, length of stay and discharge disposition after perioperative stroke in cardiac surgery using the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program database between 2005 and 2020.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
906

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

April 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

April 11, 2022

Last Update Submit

June 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death

    Death

    Within 30 days of surgery

Secondary Outcomes (2)

  • Adverse discharge

    Within 30 days of surgery

  • Length of stay

    Within 30 days of surgery

Other Outcomes (1)

  • Intensive care utilization

    Within 30 days of surgery

Interventions

Cardiac surgery (e.g. coronary bypass surgery, cardiac valve surgery, ascending aortic surgery)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who received a diagnosis of stroke in the NSQIP database after a cardiac surgical procedure between 2005 and 2020.

You may qualify if:

  • Experienced a perioperative stroke
  • Underwent cardiac surgery

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

StrokeMyocardial InfarctionCardiovascular Diseases

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Alana Flexman, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 18, 2022

Study Start

April 18, 2022

Primary Completion

October 31, 2022

Study Completion

July 1, 2023

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

The NSQIP data is available upon request to investigators at participating sites. We will not directly share our dataset as per the NSQIP Participant Data Use agreement.

Locations