Coronary Artery DiseaseNCT03770520
Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting
A study testing QFR-guided CABG and Angio-guided CABG in people with Coronary Artery Disease and Ischemic Heart Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- QFR-guided CABG and Angio-guided CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 30 Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- patients with evidence of angina pectoris
- left main or three vessels disease, have the indication for CABG after discussion of the heart team
- at least one main vessels stenosis on 40%-70%
Who cannot join
- former cardiac surgery patients
- need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy
- emergent CABG
- acute myocardial infarction time less than 7 days
- life expectancy less than 3 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Yang Zhao, MD, 86-10-64456411, allen_hya731@sohu.com
Ran Dong, MD
About this study
Official title: The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
Coronary artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.
Read the detailed description
CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Being tested
- QFR-guided CABG, Angio-guided CABG
- Keywords
- Quantitative Flow Ratio, Coronary Artery Bypass Grafting, Graft patency
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QFR-guided CABGProcedure or surgery
CABG surgery based on CAG and QFR
Angio-guided CABGProcedure or surgery
CABG surgery based on heart team discussion of CAG
| Study group | Role | What they receive |
|---|---|---|
| QFR-guided | Experimental | This group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR. Receives: Procedure: QFR-guided CABG |
| Angio-guided | Active comparator | This group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team. Receives: Procedure: Angio-guided CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of graft patency
graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result
Measured: 12 months
Secondary outcomes (2)
Major adverse cardiovascular event(MACE)
The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization
Measured: 12 months
The rate of angina relief
whether angina is relieved will be evaluated
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Feb 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion30 Aug 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Dong Ran, Beijing Anzhen Hospital
- Investigators
- Ran Dong, MD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770520
- Sponsor's protocol ID
- Z171100001017059
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- 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 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03770520
- Acronym / sponsor ID
- Z171100001017059
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Keywords
- Quantitative Flow Ratio, Coronary Artery Bypass Grafting, Graft patency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 10 Dec 2018 (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 artery bypass grafting(CABG) is the golden standard for severe coronary artery disease(CAD), the current surgery strategy is mainly based on coronary angiography(CAG), but many trials of PCI have shown that visually stenosis in CAG may not have functional significance. The aim of this study is to investigate if the Quantitative Flow Ratio (QFR) can be adopted in CABG and achieve a better graft patency.
Detailed description
CABG is the major treatment of three vessels or left main disease. CAG is the main basis on choosing the vessels to graft, however, some of the grafts occluded shortly after surgery due to competitive flow, these vessels may not be significantly stenosis in functional assessment such as Fractional Flow Reserve (FFR). Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Comparing to FFR, there is no need for pressure wire or ATP when performing QFR. This study plan to investigate the clinical effect of QFR in CABG, all patients included will be allocated 1:1 into two groups: QFR-guided and Angio-guided, QFR-guided group will be performed a CABG based on the result of QFR, the other group will be based on heart team discussion of CAG, CTA will be adopted to evaluate the 1 year graft patency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QFR-guided | Experimental | Procedure: QFR-guided CABGThis group will be performed a CABG surgery based on CAG and QFR, whether graft the moderate stenosis vessels will be based on the result of QFR. |
| Angio-guided | Active comparator | Procedure: Angio-guided CABGThis group will be performed a CABG surgery only based on CAG, the final surgery strategy will be decided after the discussion of heart team. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with evidence of angina pectoris
- left main or three vessels disease, have the indication for CABG after discussion of the heart team
- at least one main vessels stenosis on 40%-70%
Key exclusion criteria (5 listed)
- former cardiac surgery patients
- need to perform other cardiac or major surgery( i.e. valve surgery, carotid endarterectomy
- emergent CABG
- acute myocardial infarction time less than 7 days
- life expectancy less than 3 years
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 |
|---|---|---|
| QFR-guided CABGCABG surgery based on CAG and QFR | Procedure or surgery | QFR-guided |
| Angio-guided CABGCABG surgery based on heart team discussion of CAG | Procedure or surgery | Angio-guided |
Primary outcome
The rate of graft patency
Time frame: 12 months
graft patency will be evaluated by CTA, 2 doctors will be invited to read the CT and draw their own conclusion without knowing the other result
2 secondary outcomes
Major adverse cardiovascular event(MACE)
Time frame: 12 months
The rate of angina relief
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- 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.
Ran Dong, MD study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QFR-guided CABG and Angio-guided CABG in people with Coronary Artery Disease and Ischemic Heart Disease, run by Beijing Anzhen Hospital at 1 site in China.
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 3 inclusion and 5 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Yang Zhao, MD (13810050821, allen_hya731@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of graft patency (time frame: 12 months). 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 11 Dec 2018.