Coronary Artery DiseaseNCT05121610
Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- The procedures include PCI, CABG and HCR
- Type of treatment
- Surgery or procedure
- How many people
- 2,864 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Sep 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with complex coronary artery disease
Who may be able to join
- Male/female aged 18-80 years;
- Having complex coronary artery disease (SYNTAX score > 22 points) undergoing myocardial revascularization
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease
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).
- Conditions
- Coronary Artery Disease
- Being tested
- The procedures include PCI, CABG and HCR
- Keywords
- PCI, CABG, HCR, Complex coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The procedures include PCI, CABG and HCRProcedure or surgery
The procedures include PCI, CABG and HCR
| Study group | Role | What they receive |
|---|---|---|
| CABG group | CABG group Receives: Procedure: The procedures include PCI, CABG and HCR | |
| HCR group | HCR group Receives: Procedure: The procedures include PCI, CABG and HCR | |
| PCI group | PCI group Receives: Procedure: The procedures include PCI, CABG and HCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (10)
All cause death
All-cause death is defined as death from cardiovascular causes, death from non-cardiovascular causes, and death from unknown causes.
Measured: 1 year
Cardiovascular death
Cardiovascular death
Measured: 1 year
Non-fatal myocardial infarction
Non-fatal myocardial infarction
Measured: 1 year
Ischemia-driven revascularization
Ischemia-driven revascularization
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
The composite endpoints including cardiovascular death or nonfatal myocardial infarction
The composite endpoints including cardiovascular death or nonfatal myocardial infarction
Measured: 1 year
All bleeding events defined by the BARC bleeding criteria
All bleeding events defined by the BARC bleeding criteria
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,864 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Zhou, Beijing Anzhen Hospital
- Investigators
- Dongmei Shi, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121610
- Sponsor's protocol ID
- EDGE
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Revascularization Strategies on Cardiovascular Outcomes in Patients With Complex Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05121610
- Acronym / sponsor ID
- EDGE
- Conditions
- Coronary Artery Disease
- Keywords
- PCI, CABG, HCR, Complex coronary artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,864 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CABG group | – | Procedure: The procedures include PCI, CABG and HCRCABG group |
| HCR group | – | Procedure: The procedures include PCI, CABG and HCRHCR group |
| PCI group | – | Procedure: The procedures include PCI, CABG and HCRPCI group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with complex coronary artery disease
Key inclusion criteria (2 listed)
- Male/female aged 18-80 years;
- Having complex coronary artery disease (SYNTAX score > 22 points) undergoing myocardial revascularization
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The procedures include PCI, CABG and HCRThe procedures include PCI, CABG and HCR | Procedure or surgery | CABG group, HCR group, PCI group |
Primary outcome
MACCE
Time frame: 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
10 secondary outcomes
All cause death
Time frame: 1 year
Cardiovascular death
Time frame: 1 year
Non-fatal myocardial infarction
Time frame: 1 year
Ischemia-driven revascularization
Time frame: 1 year
Non-fatal stroke
Time frame: 1 year
The composite endpoints including all-cause death, non-fatal myocardial infarction, and ischemia-driven revascularization
Time frame: 1 year
The composite endpoints including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke
Time frame: 1 year
The composite endpoints including cardiovascular death or nonfatal myocardial infarction
Time frame: 1 year
All bleeding events defined by the BARC bleeding criteria
Time frame: 1 year
Type 2, 3 and 5 bleeding events defined by the BARC bleeding criteria
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongmei Shi principal investigator
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miao Yu, Doctor (13811879285, evelynym@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.