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Completed

NCT Number: NCT05036044

Stroke and Carotid-Cerebral Vascular Disease After CABG

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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Key information

Conditions

Coronary Artery Bypass

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. the incidence of 7-day neurological complications

    Time frame: within 7 days post-CABG

    a composite of stroke, delayed awakening, severe delirium

  2. the incidence of 7-day stroke

    Time frame: within 7 days post-CABG

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

  3. the incidence of delayed awakening

    Time frame: within 48 hours post-CABG

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

  4. the incidence of severe delirium

    Time frame: within 7 days post-CABG

    ICU CAM-II score≥2 points

Secondary outcomes

  1. the incidence of All-cause death

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

    Death from any cause

  2. the incidence of CV-death

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

    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

  3. the incidence of myocardial infraction

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

    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.

  4. the incidence of repeat revascularization

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

    any PCI and CABG.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

An Observational Cohort Study of Associations Between Early Neurological Complications（including Stroke）and Carotid-Cerebral Vascular Disease Among Patients After Coronary Artery Bypass Grafting

Acronym: SCCAB

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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