SCCAB-Pilot: Stroke and Carotid-Cerebral Vascular Disease After CABG - a Pilot Observation
Study Details
Study Description
Brief 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 March 2021, 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| With moderate or severe carotid-cerebral artery disease moderate (stenosis 50-69%) or severe (stenosis 70-100%) carotid-cerebral artery disease |
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| Without moderate or severe carotid-cerebral artery disease mild (stenosis 30-49%) or no (stenosis 0-29%) carotid-cerebral artery disease |
Outcome Measures
Primary Outcome Measures
- the incidence of 7-day neurological complications [within 7 days post-CABG]
a composite of stroke, delayed awakening, severe delirium
- the incidence of 7-day stroke [within 7 days post-CABG]
including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy
- the incidence of delayed awakening [within 48 hours post-CABG]
post-surgery patient does not wake up at 48 hours after withdrawing sedative
- the incidence of severe delirium [within 7 days post-CABG]
ICU CAM-II score≥2 points
Secondary Outcome Measures
- the incidence of All-cause death [7 days, 30 days and 1 year post-CABG]
Death from any cause
- the incidence of CV-death [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
- the incidence of myocardial infraction [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.
- the incidence of repeat revascularization [7 days, 30 days and 1 year post-CABG]
any PCI and CABG.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who received CABG at the Department of Cardiac Surgery in our hospital from March 2020 to March 2021.
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Surgery that patients received includes both isolated and combined CABG surgery.
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Includes both cardiopulmonary and non-cardiopulmonary bypass.
Exclusion Criteria:
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Without complete preoperative examination data, such as carotid-cerebral artery CTA, head CT imaging results and so on.
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Without complete baseline medical history and 7 day post-surgery record.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Ruijin Hospital
Investigators
- Principal Investigator: Qiang Zhao, MD, Ruijin Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY-2021127