Coronary Artery BypassSCCABNCT05036044
Stroke and Carotid-Cerebral Vascular Disease After CABG
An observational study of Coronary Artery Bypass, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass
- How many people
- 1,002 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2021to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients received CABG at the department of cardiac surgery in Ruijin hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official 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
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.
- Conditions
- Coronary Artery Bypass
- Keywords
- Neurological complications, Carotid-cerebral artery disease, CABG, CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of 7-day neurological complications
a composite of stroke, delayed awakening, severe delirium
Measured: within 7 days post-CABG
the incidence of 7-day stroke
including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy
Measured: within 7 days post-CABG
the incidence of delayed awakening
post-surgery patient does not wake up at 48 hours after withdrawing sedative
Measured: within 48 hours post-CABG
the incidence of severe delirium
ICU CAM-II score≥2 points
Measured: within 7 days post-CABG
Secondary outcomes (4)
the incidence of All-cause death
Death from any cause
Measured: 7 days, 30 days and 1 year post-CABG
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
Measured: 7 days, 30 days and 1 year post-CABG
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.
Measured: 7 days, 30 days and 1 year post-CABG
the incidence of repeat revascularization
any PCI and CABG.
Measured: 7 days, 30 days and 1 year post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start4 Sep 2021
- Primary completion21 Jan 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zhao,MD, Ruijin Hospital
- Investigators
- Qiang Zhao, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036044
- Sponsor's protocol ID
- KY-2021127
- Acronym
- SCCAB
- Status last verified
- Dec 2024
- First submitted
- 1 Sep 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05036044
- Acronym / sponsor ID
- SCCAB / KY-2021127
- Conditions
- Coronary Artery Bypass
- Keywords
- Neurological complications, Carotid-cerebral artery disease, CABG, CAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients received CABG at the department of cardiac surgery in Ruijin hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the incidence of 7-day neurological complications
Time frame: within 7 days post-CABG
a composite of stroke, delayed awakening, severe delirium
the incidence of 7-day stroke
Time frame: within 7 days post-CABG
including cerebral infarction, cerebral hemorrhage, and hypoxic-ischemic encephalopathy
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
the incidence of severe delirium
Time frame: within 7 days post-CABG
ICU CAM-II score≥2 points
4 secondary outcomes
the incidence of All-cause death
Time frame: 7 days, 30 days and 1 year post-CABG
the incidence of CV-death
Time frame: 7 days, 30 days and 1 year post-CABG
the incidence of myocardial infraction
Time frame: 7 days, 30 days and 1 year post-CABG
the incidence of repeat revascularization
Time frame: 7 days, 30 days and 1 year post-CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Zhao, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of 7-day neurological complications (time frame: within 7 days post-CABG). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.