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

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ClinicalTrials.gov Identifier: NCT03977129
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : May 12, 2022
Sponsor:
Collaborator:
Med-X Research Institute, Shanghai Jiao Tong University
Information provided by (Responsible Party):
Qiang Zhao,MD, Ruijin Hospital

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 incidence of composite outcome (MACE-5, including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and 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 MACE-5 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.

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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 : December 2023
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The 30-day incidence of composite outcome (MACE-5) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, and new renal failure requiring dialysis [ Time Frame: within 30 days after surgery ]

Secondary Outcome Measures :
  1. The time from randomization to first occurrence of any of composite outcome (MACE-6) within 1 year [ Time Frame: within 1 year after surgery ]
    The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure

  2. The incidence of 1-year 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 (MACE-6) within 3 year [ Time Frame: within 3 years after surgery ]
    The time from randomization to first occurrence of any of composite outcome (MACE-6) including all-cause death, myocardial infarction, stroke, unplanned coronary revascularization, hospitalization or urgent visits for unstable angina pectoris, and hospitalization or urgent visits for heart failure

  4. The incidence of 3-year graft failure (stenosis ≥ 50% or occlusion occurred in grafts or distal anastomosis) [ Time Frame: at 3 years after surgery ]
  5. Health-related quality of life [ Time Frame: within 30 days, 1 year and 3 years after surgery ]
    the variables are the EQ-5D scores

  6. Cost effectiveness [ Time Frame: within 30 days, 1 year and 3 years after surgery ]
    the variables are the cost increased for each composite outcome reduction at 30 days after surgery and cost increased for each additional QALY at 1 year and 3 years after surgery


Other Outcome Measures:
  1. The number of grafts per person [ Time Frame: at Day 0 ]
    counted as distal anastomosis

  2. The total circulatory time during the surgery [ Time Frame: at Day 0 ]
    minutes

  3. The total cross-clamp time during the surgery [ Time Frame: at Day 0 ]
    minutes

  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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977129


Contacts
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Contact: Yunpeng Zhu, MD. +8613816819346 Zyp12220@rjh.com.cn

Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China
Contact: Chengxin Zhang, MD       zhangchengxin@ahmu.edu.cn   
Principal Investigator: Shenglin Ge, MD         
Principal Investigator: Chengxin Zhang, MD         
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.         
China, Tianjin
Tianjin Chest Hospital Recruiting
Tianjin, Tianjin, China
Contact: Yunpeng Bai, MD       oliverwhite@126.com   
Principal Investigator: Zhigang Guo, MD         
Principal Investigator: Nan Jiang, MD         
Principal Investigator: Qinliang Chen, MD         
Sponsors and Collaborators
Ruijin Hospital
Med-X Research Institute, Shanghai Jiao Tong University
Investigators
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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
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Responsible Party: Qiang Zhao,MD, Professor and Director, Department of Cardiovascular Surgery, Vice President, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03977129    
Other Study ID Numbers: 2018CR001
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
Aortic Valve Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases