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Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting

Primary Purpose

Coronary Artery Disease, Ischemic Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
QFR-guided CABG
Angio-guided CABG
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Quantitative Flow Ratio, Coronary Artery Bypass Grafting, Graft patency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

Sites / Locations

  • Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QFR-guided

Angio-guided

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Major adverse cardiovascular event(MACE)
The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization
The rate of angina relief
whether angina is relieved will be evaluated

Full Information

First Posted
December 7, 2018
Last Updated
December 9, 2018
Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03770520
Brief Title
Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting
Official Title
The Clinical Effect of QFR-guided Coronary Artery Bypass Grafting: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Heart Disease
Keywords
Quantitative Flow Ratio, Coronary Artery Bypass Grafting, Graft patency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
QFR will be masked to care providers and participants, and open to investigators, the allocation will be based on QFR.
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QFR-guided
Arm Type
Experimental
Arm Description
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.
Arm Title
Angio-guided
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
QFR-guided CABG
Intervention Description
CABG surgery based on CAG and QFR
Intervention Type
Procedure
Intervention Name(s)
Angio-guided CABG
Intervention Description
CABG surgery based on heart team discussion of CAG
Primary Outcome Measure Information:
Title
The rate of graft patency
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major adverse cardiovascular event(MACE)
Description
The rate of deaths due to cardiovascular events, myocardial infarction and second revascularization
Time Frame
12 months
Title
The rate of angina relief
Description
whether angina is relieved will be evaluated
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Zhao, MD
Phone
13810050821
Email
allen_hya731@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Dong, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Zhao, MD
Phone
86-10-64456411
Email
allen_hya731@sohu.com
First Name & Middle Initial & Last Name & Degree
Ran Dong, MD
First Name & Middle Initial & Last Name & Degree
Yang Zhao, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Graft Patency of QFR-guided Versus Angio-guided Coronary Artery Bypass Grafting

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