Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)
1 other identifier
observational
2,864
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 16, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedNovember 16, 2021
November 1, 2021
9 months
November 4, 2021
November 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
All cause death
1 year
Cardiovascular death
1 year
Non-fatal myocardial infarction
1 year
Ischemia-driven revascularization
1 year
Non-fatal stroke
1 year
- +5 more secondary outcomes
Study Arms (3)
CABG group
CABG group
HCR group
HCR group
PCI group
PCI group
Interventions
The procedures include PCI, CABG and HCR
Eligibility Criteria
Patients with complex coronary artery disease
You may qualify if:
- Male/female aged 18-80 years;
- Having complex coronary artery disease (SYNTAX score \> 22 points) undergoing myocardial revascularization
You may not qualify if:
- Cardiogenic shock or hemodynamic instability;
- Undergoing other heart surgery at the same time;
- Previous coronary artery bypass surgery;
- History of cerebral hemorrhage;
- Ischemic stroke in the past six months;
- History of cancer;
- Life expectancy no more than 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dongmei Shi
Beijing Anzhen Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 16, 2021
Study Start
December 1, 2021
Primary Completion
September 1, 2022
Study Completion
September 1, 2023
Last Updated
November 16, 2021
Record last verified: 2021-11