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出境医 / 临床实验 / Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease (FAVOR4-QVAS)

Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease (FAVOR4-QVAS)

Study Description
Brief Summary:
This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the effectiveness of an Quantitative Flow Ratio (QFR)-guided revascularization strategy and a coronary angiography (CAG)-guided revascularization strategy in preventing the composite outcome (including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, new renal failure requiring dialysis) within 30 days after surgery. The study hypothesis is that the QFR-guided strategy can reduce the incidence of the composite outcome within 30 days after surgery, as compared with the CAG-guided strategy.

Condition or disease Intervention/treatment Phase
Primary Valvular Heart Disease With Comorbid Coronary Artery Disease Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease Device: QFR-guided strategy Other: CAG-guided strategy Not Applicable

Detailed Description:

It is planned to enroll 792 subjects aged ≥18 years, with no gender restriction, who plan to undergo elective open-heart valvular surgery due to primary valvular heart disease, with comorbid coronary artery lesions defined as diameter stenosis of ≥ 50% (visual estimation) that are diagnosed by CAG before the surgery.

QFR group: Calculate the QFR values of all target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out.

CAG group (control group): All target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization will undergo simultaneous CABG revascularization.

Intervention duration: The assessments will be performed after randomization and before the surgery to guide the surgery.

No planned interim analysis.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Prospective, Randomized, Blind, Controlled Clinical Study to Compare the Efficacy of Quantitative Flow Ratio Guided and Coronary Angiography Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
Actual Study Start Date : August 4, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: QFR group Device: QFR-guided strategy
In this study, the QFR-guided strategy will be applied to in the QFR group in which calculation of the QFR values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to CABG revascularization will be carried out. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out.
Active Comparator: CAG group Other: CAG-guided strategy
In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.
Outcome Measures
Primary Outcome Measures :
  1. The incidence of composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization and new renal failure requiring dialysis [ Time Frame: within 30 days after surgery ]
    Compare the incidence of composite outcome between two groups.


Secondary Outcome Measures :
  1. The time from randomization to first occurrence of any of composite outcome [ Time Frame: within 1 year after surgery ]
    The time from randomization to first occurrence of any of composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris and hospitalization or urgent visits for heart failure

  2. The incidence of graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) [ Time Frame: at 1 year after surgery ]
  3. The time from randomization to first occurrence of any of composite outcome [ Time Frame: within 3 years after surgery ]
    The time from randomization to first occurrence of any of composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris and hospitalization or urgent visits for heart failure

  4. The incidence of graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) [ Time Frame: at 3 years after surgery ]

Other Outcome Measures:
  1. The number of grafts per person (counted as distal anastomosis) [ Time Frame: at Day 0 ]
  2. The total circulatory time during the surgery (minutes) [ Time Frame: at Day 0 ]
  3. The total cross-clamp time during the surgery (minutes) [ Time Frame: at Day 0 ]
  4. The total units of erythrocyte transfusion during and after the surgery till discharge [ Time Frame: from Day 0 to discharge day ]
  5. The number of days from surgery day to discharge day [ Time Frame: from Day 0 to discharge day ]
  6. Change from baseline in the Canadian Cardiac Society (CCS) anginal status score (0-4) [ Time Frame: at 1 year after surgery ]
  7. Change from baseline in the CCS anginal status score (0-4) [ Time Frame: at 3 years after surgery ]
  8. Change from baseline in the New York Heart Association (NYHA) score (1-4) [ Time Frame: at 1 year after surgery ]
  9. Change from baseline in the NYHA score (1-4) [ Time Frame: at 3 years after surgery ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntarily participate in the trial and provide the informed consent form;
  • Male or female patients aged ≥ 18 years;
  • Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease (such as rheumatic, degenerative, infective, congenital valvular heart disease, etc.);
  • At least one target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with preoperative diameter stenosis of ≥ 50% by coronary angiography (visual estimation, subject to written coronary angiography report) and suited for CABG revascularization.

Exclusion Criteria:

  • History of heart surgery;
  • Planned second-stage PCI or CABG revascularization;
  • Secondary valvular heart disease (ischemia, cardiomyopathy);
  • Planned valve intervention surgery through the catheter;
  • Subjects that were evaluated to have cardiogenic shock or other critical conditions that were not appropriate for the trial by study physician;
  • QFR calculations cannot be carried out from preoperative coronary angiography data (such as poor projection position, inability to detect vascular boundaries, poor contrast agent filling, excessive overlap or severely distorted of vessel lesion sections, lesion involved in myocardial bridge, or lesion site within 3 mm from the ostium of the main coronary artery);
  • The target coronary arteries were evaluated to be not suitable for CABG by study physician;
  • Life expectancy < 3 years.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Yunpeng Zhu, MD. +8613816819346 Zyp12220@rjh.com.cn

Locations
Layout table for location information
China, Henan
Fuwai Central China Cardiovascular Hospital Recruiting
Zhengzhou, Henan, China
Contact: Junlong Hu, MD.       dr_hu@henu.edu.cn   
Principal Investigator: Zhaoyun Cheng, MD.         
Sub-Investigator: Junlong Hu, MD.         
China, Hunan
The Second XiangYa Hospital of Central South University Recruiting
Changsha, Hunan, China
Contact: Yuan Zhao, MD.       drzhaoyuan@163.com   
Principal Investigator: Xinmin Zhou, MD.         
Principal Investigator: Yuan Zhao, MD.         
Sub-Investigator: Kang Zhou, MD.         
China, Shanghai
Ruijin Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Yunpeng Zhu, MD.    +8613816819346    Zyp12220@rjh.com.cn   
Principal Investigator: Qiang Zhao, MD.         
Principal Investigator: Yunpeng Zhu, MD.         
Sub-Investigator: Jiaxi Zhu, MD.         
Sub-Investigator: Yiwei Xu, MD.         
Changhai Hospital of Shanghai Recruiting
Shanghai, Shanghai, China
Contact: Qing Xue, MD.       xq9911310@163.com   
Principal Investigator: Zhiyun Xu, MD.         
Principal Investigator: Lin Han, MD.         
Sub-Investigator: Qing Xue, MD.         
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China
Contact: Busheng Zhang, MD.       albmu@sina.cn   
Principal Investigator: Dan Zhu, MD.         
Sub-Investigator: Busheng Zhang, MD.         
Sponsors and Collaborators
Ruijin Hospital
Med-X Research Institute, Shanghai Jiao Tong University
Investigators
Layout table for investigator information
Principal Investigator: Qiang Zhao, MD. Ruijin Hospital
Principal Investigator: Shengxian Tu, PhD. Med-X Research Institute, Shanghai Jiao Tong University
Study Director: Yunpeng Zhu, MD. Ruijin Hospital
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE August 4, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019) 		The incidence of composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization and new renal failure requiring dialysis [ Time Frame: within 30 days after surgery ]
Compare the incidence of composite outcome between two groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • The time from randomization to first occurrence of any of composite outcome [ Time Frame: within 1 year after surgery ]
    The time from randomization to first occurrence of any of composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris and hospitalization or urgent visits for heart failure
  • The incidence of graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) [ Time Frame: at 1 year after surgery ]
  • The time from randomization to first occurrence of any of composite outcome [ Time Frame: within 3 years after surgery ]
    The time from randomization to first occurrence of any of composite outcome including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris and hospitalization or urgent visits for heart failure
  • The incidence of graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) [ Time Frame: at 3 years after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 5, 2019)
  • The number of grafts per person (counted as distal anastomosis) [ Time Frame: at Day 0 ]
  • The total circulatory time during the surgery (minutes) [ Time Frame: at Day 0 ]
  • The total cross-clamp time during the surgery (minutes) [ Time Frame: at Day 0 ]
  • The total units of erythrocyte transfusion during and after the surgery till discharge [ Time Frame: from Day 0 to discharge day ]
  • The number of days from surgery day to discharge day [ Time Frame: from Day 0 to discharge day ]
  • Change from baseline in the Canadian Cardiac Society (CCS) anginal status score (0-4) [ Time Frame: at 1 year after surgery ]
  • Change from baseline in the CCS anginal status score (0-4) [ Time Frame: at 3 years after surgery ]
  • Change from baseline in the New York Heart Association (NYHA) score (1-4) [ Time Frame: at 1 year after surgery ]
  • Change from baseline in the NYHA score (1-4) [ Time Frame: at 3 years after surgery ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Quantitative Flow Ratio (QFR) Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
Official Title  ICMJE A Multicenter, Prospective, Randomized, Blind, Controlled Clinical Study to Compare the Efficacy of Quantitative Flow Ratio Guided and Coronary Angiography Guided Revascularization Strategy for Patients Undergoing Primary Valve Surgery With Comorbid Coronary Artery Disease
Brief Summary This is a multicenter, prospective, randomized, blinded, controlled clinical study in patients with planned primary valvular surgery and comorbid coronary artery lesions with diameter stenosis of ≥ 50%, to compare the effectiveness of an Quantitative Flow Ratio (QFR)-guided revascularization strategy and a coronary angiography (CAG)-guided revascularization strategy in preventing the composite outcome (including all-cause death, non-fatal myocardial infarction, non-fatal stroke, unplanned coronary revascularization, new renal failure requiring dialysis) within 30 days after surgery. The study hypothesis is that the QFR-guided strategy can reduce the incidence of the composite outcome within 30 days after surgery, as compared with the CAG-guided strategy.
Detailed Description

It is planned to enroll 792 subjects aged ≥18 years, with no gender restriction, who plan to undergo elective open-heart valvular surgery due to primary valvular heart disease, with comorbid coronary artery lesions defined as diameter stenosis of ≥ 50% (visual estimation) that are diagnosed by CAG before the surgery.

QFR group: Calculate the QFR values of all target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out.

CAG group (control group): All target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with lesions with diameter stenosis of ≥ 50% (visual estimation) suited for CABG revascularization will undergo simultaneous CABG revascularization.

Intervention duration: The assessments will be performed after randomization and before the surgery to guide the surgery.

No planned interim analysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Primary Valvular Heart Disease With Comorbid Coronary Artery Disease
  • Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease
Intervention  ICMJE
  • Device: QFR-guided strategy
    In this study, the QFR-guided strategy will be applied to in the QFR group in which calculation of the QFR values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to CABG revascularization will be carried out. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out.
  • Other: CAG-guided strategy
    In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.
Study Arms  ICMJE
  • Experimental: QFR group
    Intervention: Device: QFR-guided strategy
  • Active Comparator: CAG group
    Intervention: Other: CAG-guided strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019) 		792
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Voluntarily participate in the trial and provide the informed consent form;
  • Male or female patients aged ≥ 18 years;
  • Planned to undergo elective on-pump valve surgery due to primary mitral and/or aortic valvular heart disease (such as rheumatic, degenerative, infective, congenital valvular heart disease, etc.);
  • At least one target coronary arteries (anterior descending branch, circumflex branch, main right coronary artery or its primary branches with ≥ 1.5 mm in diameter, such as diagonal branch, intermediate branch, obtuse marginal branch, posterior descending branch and posterior branch of left ventricle) with preoperative diameter stenosis of ≥ 50% by coronary angiography (visual estimation, subject to written coronary angiography report) and suited for CABG revascularization.

Exclusion Criteria:

  • History of heart surgery;
  • Planned second-stage PCI or CABG revascularization;
  • Secondary valvular heart disease (ischemia, cardiomyopathy);
  • Planned valve intervention surgery through the catheter;
  • Subjects that were evaluated to have cardiogenic shock or other critical conditions that were not appropriate for the trial by study physician;
  • QFR calculations cannot be carried out from preoperative coronary angiography data (such as poor projection position, inability to detect vascular boundaries, poor contrast agent filling, excessive overlap or severely distorted of vessel lesion sections, lesion involved in myocardial bridge, or lesion site within 3 mm from the ostium of the main coronary artery);
  • The target coronary arteries were evaluated to be not suitable for CABG by study physician;
  • Life expectancy < 3 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yunpeng Zhu, MD. +8613816819346 Zyp12220@rjh.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03977129
Other Study ID Numbers  ICMJE 2018CR001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Qiang Zhao,MD, Ruijin Hospital
Study Sponsor  ICMJE Ruijin Hospital
Collaborators  ICMJE Med-X Research Institute, Shanghai Jiao Tong University
Investigators  ICMJE
Principal Investigator: Qiang Zhao, MD. Ruijin Hospital
Principal Investigator: Shengxian Tu, PhD. Med-X Research Institute, Shanghai Jiao Tong University
Study Director: Yunpeng Zhu, MD. Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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