Coronary Artery DiseaseNCT04935086
Risk Factors for Predictors of MACEs After RA-CABG
An observational study of Coronary Artery Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
As the secondary choice of artery grafts, radial artery is more and more used to achieve multiple arterial revascularization in CABG. Risk factors for predictors of major cardiovascular adverse events (MACE) after CABG using radial-artery grafts (RA-CABG), however, remain uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 30 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18-year and above underwent RA-CABG from Jan. 2009 to Dec.2019 in one single center.
Who may be able to join
- Underwent CABG using at least a radial artery grafts from Jan.2009 to Dec.2019. with or without cardiopulmonary bypass , with or without concomitant procedure
- Aged 18 and above at procedure
- With any gender
Who cannot join
- With unavailable medical records
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: Risk Factors for Predictors of Major Adverse Cardiovascular Events After Coronary Artery Bypass Using Radial Artery Grafts
As the secondary choice of artery grafts, radial artery is more and more used to achieve multiple arterial revascularization in CABG. Risk factors for predictors of major cardiovascular adverse events (MACE) after CABG using radial-artery grafts (RA-CABG), however, remain uncertain. This case-control study aims to identify the baseline predictors of MACE after RA-CABG.
We will collect the baseline characteristics and perioperative data of patients underwent RA-CABG from Jan. 2009 to Dec. 2019 in our single center. By reviewing the latest follow-up records, we will examine the correlation between the baseline characteristics and clinical outcomes (MACEs), then identify the independent risk factors for predictors of MACEs after RA-CABG.
- Conditions
- Coronary Artery Disease
- Keywords
- Risk Factors, CABG, Radial Artery, MACE
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| MACE Group | MACE Group includes the patients suffered from any component of MACE after RA-CABG until the latest follow-up. | |
| Non-MACE Group | Non-MACE Group includes the patients freed from any component of MACE after RA-CABG until the latest follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day MACE-4
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
Measured: 7 days post-CABG
30-day MACE-4
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
Measured: 30 days post-CABG
1-year MACE-4
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
Measured: 1 year post-CABG
3-year MACE-4
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
Measured: 3 years post-CABG
Secondary outcomes (6)
MACE-3
a composite of CV-death, myocardial infraction and stroke
Measured: 7 days, 30 days, 1 year, and 3 years post-CABG
All-cause death
Death from any cause
Measured: 7 days, 30 days, 1 year, and 3 years post-CABG
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, 1 year, and 3 years post-CABG
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, 1 year, and 3 years post-CABG
Stroke
According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including ischemic, hemorrhagic and unknown type.
Measured: 7 days, 30 days, 1 year, and 3 years post-CABG
Repeat revascularization
According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including any PCI and CABG.
Measured: 7 days, 30 days, 1 year, and 3 years post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start30 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 370 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 HospitalYunpeng Zhu, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935086
- Sponsor's protocol ID
- KY-2020388
- Status last verified
- Dec 2024
- First submitted
- 3 Jun 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
Publications
Xia T, Li B, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Zhu Y, Zhao Q. Risk factors for major adverse cardiovascular events after coronary artery bypass grafting using radial artery grafts. Front Cardiovasc Med. 2023 Sep 27;10:1238161. doi: 10.3389/fcvm.2023.1238161. eCollection 2023.
PubMed 37829689
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
- Risk Factors for Predictors of Major Adverse Cardiovascular Events After Coronary Artery Bypass Using Radial Artery Grafts
- ClinicalTrials.gov ID
- NCT04935086
- Acronym / sponsor ID
- KY-2020388
- Conditions
- Coronary Artery Disease
- Keywords
- Risk Factors, CABG, Radial Artery, MACE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 22 Jun 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.
As the secondary choice of artery grafts, radial artery is more and more used to achieve multiple arterial revascularization in CABG. Risk factors for predictors of major cardiovascular adverse events (MACE) after CABG using radial-artery grafts (RA-CABG), however, remain uncertain. This case-control study aims to identify the baseline predictors of MACE after RA-CABG.
We will collect the baseline characteristics and perioperative data of patients underwent RA-CABG from Jan. 2009 to Dec. 2019 in our single center. By reviewing the latest follow-up records, we will examine the correlation between the baseline characteristics and clinical outcomes (MACEs), then identify the independent risk factors for predictors of MACEs after RA-CABG.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACE Group | – | –MACE Group includes the patients suffered from any component of MACE after RA-CABG until the latest follow-up. |
| Non-MACE Group | – | –Non-MACE Group includes the patients freed from any component of MACE after RA-CABG until the latest follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18-year and above underwent RA-CABG from Jan. 2009 to Dec.2019 in one single center.
Key inclusion criteria (3 listed)
- Underwent CABG using at least a radial artery grafts from Jan.2009 to Dec.2019. with or without cardiopulmonary bypass , with or without concomitant procedure
- Aged 18 and above at procedure
- With any gender
Key exclusion criteria (1 listed)
- With unavailable medical records
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
7-day MACE-4
Time frame: 7 days post-CABG
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
30-day MACE-4
Time frame: 30 days post-CABG
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
1-year MACE-4
Time frame: 1 year post-CABG
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
3-year MACE-4
Time frame: 3 years post-CABG
a composite of all-cause death, myocardial infraction, stroke and repeat revascularization
6 secondary outcomes
MACE-3
Time frame: 7 days, 30 days, 1 year, and 3 years post-CABG
All-cause death
Time frame: 7 days, 30 days, 1 year, and 3 years post-CABG
CV-death
Time frame: 7 days, 30 days, 1 year, and 3 years post-CABG
Myocardial infraction
Time frame: 7 days, 30 days, 1 year, and 3 years post-CABG
Stroke
Time frame: 7 days, 30 days, 1 year, and 3 years post-CABG
Repeat revascularization
Time frame: 7 days, 30 days, 1 year, and 3 years 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.
- Results publication: PubMed 37829689Xia T, Li B, Zhang W, Wang Z, Ye X, Zhou M, Li H, Qiu J, Zhu Y, Zhao Q. Risk factors for major adverse cardiovascular events after coronary artery bypass grafting using radial artery grafts. Front Cardiovasc Med. 2023 Sep 27;10:1238161. doi: 10.3389/fcvm.2023.1238161. eCollection 2023.
- Individual participant dataSharing planned: No
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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
Yunpeng Zhu, 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 Disease, 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 1 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?
7-day MACE-4 (time frame: 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?
On the ClinicalTrials.gov record for NCT04935086, which also lists 1 linked publication.
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.