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CompletedNCT05036044SCCABUpdated Dec 12, 2024

Stroke and Carotid-Cerebral Vascular Disease After CABG

An observational study in Coronary Artery Bypass, sponsored by Ruijin Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,002
Sex
All
01

Study summary

Review the data of patients who underwent coronary artery bypass grafting (CABG) at the Department of Cardiovascular Surgery in Ruijin hospital from March 2020 to May 2022, including medical history, head and neck CTA, head CT scan, and early postoperative (within 7 days after surgery) neurological complications (defined as a composite of stroke, delayed awakening and severe delirium) . Case-control and retrospective cohorts were built to explore risk factors of early postoperative neurological complications, And its association with baseline carotid-cerebral vascular disease.

Describe the epidemiological data of early postoperative neurological complications (stroke, delayed awakening, and severe delirium) after CABG surgery (within 7 days after surgery); explore independent risk factors of compound neurological complications, build predictive models; compare the effects of carotid-cerebral artery disease on early postoperative compound neurological complications.

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Conditions studied

  • Coronary Artery Bypass

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Keywords

  • Neurological complications
  • Carotid-cerebral artery disease
  • CABG
  • CAD
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 1,002 is above the median of 200 across 301 observational studies indexed under Vascular Diseases.

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Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients received CABG at the department of cardiac surgery in Ruijin hospital.

Inclusion criteria

  1. Patients who received CABG at the department of cardiac surgery in our hospital.
  2. Surgery that patients received includes both isolated and combined CABG surgery.
  3. Includes both cardiopulmonary and non-cardiopulmonary bypass.

Exclusion criteria

Exclusion Criteria:

  1. Without complete preoperative examination data, such as carotid-cerebral artery CTA, head CT imaging results and so on.
  2. Without complete baseline medical history and 7 day post-surgery record.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,002 participants (actual)
Patient registry
No

Groups and cohorts

  • With moderate or severe carotid-cerebral artery disease

    moderate (stenosis 50-69%) or severe (stenosis 70-100%) carotid-cerebral artery disease

  • Without moderate or severe carotid-cerebral artery disease

    mild (stenosis 30-49%) or no (stenosis 0-29%) carotid-cerebral artery disease

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What researchers measure

Primary outcomes

  1. the incidence of 7-day neurological complications

    a composite of stroke, delayed awakening, severe delirium

    Time frame: within 7 days post-CABG

  2. the incidence of 7-day stroke

    including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy

    Time frame: within 7 days post-CABG

  3. the incidence of delayed awakening

    post-surgery patient does not wake up at 48 hours after withdrawing sedative

    Time frame: within 48 hours post-CABG

  4. the incidence of severe delirium

    ICU CAM-II score≥2 points

    Time frame: within 7 days post-CABG

Secondary outcomes

  1. the incidence of All-cause death

    Death from any cause

    Time frame: 7 days, 30 days and 1 year post-CABG

  2. the incidence of CV-death

    Including death resulting from an acute myocardial infarction , sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, and death due to other cardiovascular causes

    Time frame: 7 days, 30 days and 1 year post-CABG

  3. the incidence of myocardial infraction

    According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including CABG-related MI, non CABG-related MI, silent MI and unknown type.

    Time frame: 7 days, 30 days and 1 year post-CABG

  4. the incidence of repeat revascularization

    any PCI and CABG.

    Time frame: 7 days, 30 days and 1 year post-CABG

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Study locations

1 site
  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200025, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05036044
Lead sponsor
Ruijin Hospital
Responsible party
Qiang Zhao,MD (Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital, Ruijin Hospital) — Principal investigator
First posted
Sep 5, 2021
Start date
Sep 4, 2021
Primary completion
Jan 21, 2023
Completion
May 31, 2023
Last update
Dec 12, 2024

Study contacts

Qiang Zhao, MD
principal investigator · Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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