Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)

Coronary Artery Disease Clinical Trial

Official title:

Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05121610
• Other study ID #: EDGE
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2021
• Source: Beijing Anzhen Hospital
• Contact: Miao Yu, Doctor
• Phone: 13811879285
• Email: evelynym[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Coronary heart disease is one of the most serious diseases that endanger people's health. Complex coronary artery disease is critical and has high mortality. Therefore, it is urgent to explore the best treatment method for complex coronary artery disease. Some previous studies have shown that patients with left main coronary artery disease with a SYNTAX score> 32 points, and diabetic/non-diabetic three-vessel disease patients with coronary heart disease with a SYNTAX score > 22 points, CABG is recommended for revascularization. However, with the continuous innovation of surgical technology and the rapid development of surgical instruments, the treatment of patients with complex coronary artery disease is increasing. Therefore, it is necessary to investigate the effects of different revascularization strategies on long-term prognosis in patients with complex coronary artery disease (SYNTAX score > 22 points).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2864
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male/female aged 18-80 years;

2. Having complex coronary artery disease (SYNTAX score > 22 points) undergoing myocardial revascularization

Exclusion Criteria:

1. Cardiogenic shock or hemodynamic instability;

2. Undergoing other heart surgery at the same time;

3. Previous coronary artery bypass surgery;

4. History of cerebral hemorrhage;

5. Ischemic stroke in the past six months;

6. History of cancer;

7. Life expectancy no more than 12 months

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• The procedures include PCI, CABG and HCR
The procedures include PCI, CABG and HCR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE	Major adverse cardiovascular and cerebrovascular events (MACCE) at 1 year, including all-cause death, non-fatal myocardial infarction, ischemia-driven revascularization, and non-fatal stroke	1 year
Secondary	All cause death	All-cause death is defined as death from cardiovascular causes, death from non-cardiovascular causes, and death from unknown causes.	1 year
Secondary	Cardiovascular death	Cardiovascular death	1 year
Secondary	Non-fatal myocardial infarction	Non-fatal myocardial infarction	1 year
Secondary	Ischemia-driven revascularization	Ischemia-driven revascularization	1 year
Secondary	Non-fatal stroke	Stroke is defined as a neurological deficit with symptoms or signs that last at least 24 hours and imaging studies (CT or MRI) confirm the presence of cerebral infarction or cerebral hemorrhage.	1 year
Secondary	The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization	The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization	1 year
Secondary	The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke	The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke	1 year
Secondary	The composite endpoints including cardiovascular death or nonfatal myocardial infarction	The composite endpoints including cardiovascular death or nonfatal myocardial infarction	1 year
Secondary	All bleeding events defined by the BARC bleeding criteria	All bleeding events defined by the BARC bleeding criteria	1 year
Secondary	Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria	Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria	1 year