Risk Factors for Predictors of MACEs After RA-CABG

Coronary Artery Disease Clinical Trial

Official title:

Risk Factors for Predictors of Major Adverse Cardiovascular Events After Coronary Artery Bypass Using Radial Artery Grafts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935086
• Other study ID #: KY-2020388
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• With unavailable medical records

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day MACE-4	a composite of all-cause death, myocardial infraction, stroke and repeat revascularization	7 days post-CABG
Primary	30-day MACE-4	a composite of all-cause death, myocardial infraction, stroke and repeat revascularization	30 days post-CABG
Primary	1-year MACE-4	a composite of all-cause death, myocardial infraction, stroke and repeat revascularization	1 year post-CABG
Primary	3-year MACE-4	a composite of all-cause death, myocardial infraction, stroke and repeat revascularization	3 years post-CABG
Secondary	MACE-3	a composite of CV-death, myocardial infraction and stroke	7 days, 30 days, 1 year, and 3 years post-CABG
Secondary	All-cause death	Death from any cause	7 days, 30 days, 1 year, and 3 years post-CABG
Secondary	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	7 days, 30 days, 1 year, and 3 years post-CABG
Secondary	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.	7 days, 30 days, 1 year, and 3 years post-CABG
Secondary	Stroke	According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including ischemic, hemorrhagic and unknown type.	7 days, 30 days, 1 year, and 3 years post-CABG
Secondary	Repeat revascularization	According to the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials, including any PCI and CABG.	7 days, 30 days, 1 year, and 3 years post-CABG