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

• Sponsor: Beijing Anzhen Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05121610
• Collaborator: (none)
• Enrollment: 2,864
• Anticipated Duration (Months): 21

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: The procedures include PCI, CABG and HCR

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 2864 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease
• Anticipated Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
CABG group CABG group	Procedure: The procedures include PCI, CABG and HCR; The procedures include PCI, CABG and HCR
HCR group HCR group	Procedure: The procedures include PCI, CABG and HCR; The procedures include PCI, CABG and HCR
PCI group PCI group	Procedure: The procedures include PCI, CABG and HCR; The procedures include PCI, CABG and HCR

Outcome Measures

Primary Outcome Measures

1. MACCE [1 year]

   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

Secondary Outcome Measures

1. All cause death [1 year]

   All-cause death is defined as death from cardiovascular causes, death from non-cardiovascular causes, and death from unknown causes.

2. Cardiovascular death [1 year]

   Cardiovascular death

3. Non-fatal myocardial infarction [1 year]

   Non-fatal myocardial infarction

4. Ischemia-driven revascularization [1 year]

   Ischemia-driven revascularization

5. Non-fatal stroke [1 year]

   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.

6. The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization [1 year]

   The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization

7. The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [1 year]

   The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke

8. The composite endpoints including cardiovascular death or nonfatal myocardial infarction [1 year]

   The composite endpoints including cardiovascular death or nonfatal myocardial infarction

9. All bleeding events defined by the BARC bleeding criteria [1 year]

   All bleeding events defined by the BARC bleeding criteria

10. Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria [1 year]

    Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Beijing Anzhen Hospital

Investigators

• Principal Investigator: Dongmei Shi, Beijing Anzhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yujie Zhou, Principal Investigator, Beijing Anzhen Hospital
• ClinicalTrials.gov Identifier: NCT05121610
• Other Study ID Numbers: EDGE
• First Posted: Nov 16, 2021
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yujie Zhou, Principal Investigator, Beijing Anzhen Hospital: PCI; CABG; HCR; Complex coronary artery disease
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Nov 16, 2021