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

NCT ID: NCT05121610

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2864 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-09-01

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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PCI CABG HCR Complex coronary artery disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CABG group

CABG group

The procedures include PCI, CABG and HCR

Intervention Type PROCEDURE

The procedures include PCI, CABG and HCR

HCR group

HCR group

The procedures include PCI, CABG and HCR

Intervention Type PROCEDURE

The procedures include PCI, CABG and HCR

PCI group

PCI group

The procedures include PCI, CABG and HCR

Intervention Type PROCEDURE

The procedures include PCI, CABG and HCR

Interventions

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The procedures include PCI, CABG and HCR

The procedures include PCI, CABG and HCR

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yujie Zhou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongmei Shi

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Central Contacts

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Miao Yu, Doctor

Role: CONTACT

Phone: 13811879285

Email: [email protected]

Other Identifiers

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EDGE

Identifier Type: -

Identifier Source: org_study_id