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出境医 / 临床实验 / Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND)

Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND)

Study Description
Brief Summary:
The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease.

Condition or disease Intervention/treatment Phase
Non-obstructive Coronary Artery Disease Other: Endothelial function guided therapy Not Applicable

Detailed Description:
The study will be carried out in two stages. Phase I is mainly intended to evaluate the effects of vascular EFT on the prescription of doctors and the application rate of mid and long-term secondary prevention medication in patients. If the results are positive, the sample size and observation time will be further expanded in Phase II to evaluate its impact on the cardiovascular events of patients, as well as its cost-effectiveness.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multicenter, randomized, patient and assessor blinded, parallel control, two-stage, clinical trial.

Phase I: a feasibility study to collect data on key process outcomes including physician's prescription behaviors, patients' cardiovascular risk, and trend of reduction in cardiovascular events, To create an initial and to inform for the Phase II larger multicenter trial on choosing clinical endpoints and sample size.

Phase II: will extend all patients from Phase I to a longer period of follow up and recruit more new patients to enlarge the sample size, in order to have a full study on the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with NOCAD.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This study is patient and assessor blinded; that is, both groups of patients are unaware of the endothelial function results. This study will use blind methods for endpoint data collectors; that is, the data collectors will collect secondary prevention medication and cardiovascular event data for coronary artery disease without an awareness of patient grouping.
Primary Purpose: Other
Official Title: Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention group
Intervention group: Before the patient returns to the doctor and the prescription is issued, the EDCM system will feed back the EndoPAT test results to the responsible doctor through the automatically generated information on the doctor's mobile phone, but will not let the patient know the endothelium test results (blinded to the patient).
 Other: Endothelial function guided therapy
To evaluate the effect of integration of non invasive endothelial function test (EFT) as a routine test in increasing appropriate treatment to reduce cardiovascular risk including prescription of lipid, blood pressure and glucose lowering medications by physicians at the clinic for patients with non-obstructive coronary artery disease (NOCAD) and the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with non-obstructive coronary artery disease(NOCAD).
No Intervention: Control group
Control group: The EDCM system will not report the EndoPAT test results to the responsible doctor (the doctor cannot see the final EFT results), nor can the patients know the EFT results.
Outcome Measures
Primary Outcome Measures :
  1. Compliance rate of patients to physicians prescription [ Time Frame: up to 30 months ]
    The incidence number of patients compliance to guidelines based medical therapy with prescription of cholesterol, blood pressure and glucose lowering medications by physicians at clinic for patients with non-obstructive coronary artery disease.

  2. Total incidence number of Major Adverse Cardiovascular Events [ Time Frame: up to 54 months ]
    The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).


Secondary Outcome Measures :
  1. Mean improvement of endothelial function [ Time Frame: up to 30 months ]
    The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).

  2. Incidence number of Major Adverse Cardiovascular Events [ Time Frame: up to 30 months ]
    The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months

  3. Reduction of lipid levels [ Time Frame: up to 30 months ]
    The reduction in lipid levels from baseline to 12 months

  4. Reduction of blood pressure [ Time Frame: up to 30 months ]
    The reduction in blood pressure from baseline to 12 months

  5. Compliance rate of patients with treatment target [ Time Frame: up to 30 months ]
    The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.

  6. Compliance rate of patients with appropriate prescription by physicians [ Time Frame: up to 30 months ]
    The percentage of patients with appropriate prescription of cholesterol, blood pressure and glucose lowering medications by physicians at 3, 6 and 12 months after baseline.

  7. Compliance rate of patients with healthy life style [ Time Frame: up to 30 months ]
    The percentage of patients with healthy life style at 3, 6 and 12 months after baseline. The healthy life style is defined as having no smoking, physical activities with at least 3 times a week and 30 min per time, BMI<25 Kg/M2.

  8. Cost-effectiveness rate of Endothelial Function Testing [ Time Frame: up to 54 months ]
    The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .


Eligibility Criteria
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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:

  • 1. Age: 18 years or older;
  • 2. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
  • 3. Having signed their written informed consent.

Exclusion Criteria:

  • 1. Left ventricular ejection fraction ≤ 50%;
  • 2. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
  • 3. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
  • 4. Severe nephropathy (uremia, renal failure);
  • 5. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
  • 6. Malignant tumor;
  • 7. Mental disorders or cognitive disorders;
  • 8. Participating in other interventional clinical trials;
  • 9. There are any other factors that the treating doctors think are not suitable for inclusion or completion of this study.
Contacts and Locations

Contacts
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Contact: Huan LIU, MSc 15650783607 liuhuan07@bjmu.edu.cn
Contact: Yao LU, MSc 18500655509 luyao_pucri@bjmu.edu.cn

Locations
Layout table for location information
China
Peking University Shougang Hospital Recruiting
Beijing, China
Contact: Hongyu Wang, MD    13910906891    dr.hongyuwang@foxmail.com   
Principal Investigator: Hongyu Wang, MD         
Sponsors and Collaborators
Peking University
Mayo Clinic
Peking University Shougang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hongyu Wang, MD Peking University
Study Director: Gaoqiang Xie, PHD Peking University
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Compliance rate of patients to physicians prescription [ Time Frame: up to 30 months ]
    The incidence number of patients compliance to guidelines based medical therapy with prescription of cholesterol, blood pressure and glucose lowering medications by physicians at clinic for patients with non-obstructive coronary artery disease.
  • Total incidence number of Major Adverse Cardiovascular Events [ Time Frame: up to 54 months ]
    The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • Compliance [ Time Frame: up to 30 months ]
    The incidence number of patients compliance to guidelines based medical therapy with prescription of cholesterol, blood pressure and glucose lowering medications by physicians at clinic for patients with non-obstructive coronary artery disease.
  • Incidence [ Time Frame: up to 54 months ]
    The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Mean improvement of endothelial function [ Time Frame: up to 30 months ]
    The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
  • Incidence number of Major Adverse Cardiovascular Events [ Time Frame: up to 30 months ]
    The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
  • Reduction of lipid levels [ Time Frame: up to 30 months ]
    The reduction in lipid levels from baseline to 12 months
  • Reduction of blood pressure [ Time Frame: up to 30 months ]
    The reduction in blood pressure from baseline to 12 months
  • Compliance rate of patients with treatment target [ Time Frame: up to 30 months ]
    The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.
  • Compliance rate of patients with appropriate prescription by physicians [ Time Frame: up to 30 months ]
    The percentage of patients with appropriate prescription of cholesterol, blood pressure and glucose lowering medications by physicians at 3, 6 and 12 months after baseline.
  • Compliance rate of patients with healthy life style [ Time Frame: up to 30 months ]
    The percentage of patients with healthy life style at 3, 6 and 12 months after baseline. The healthy life style is defined as having no smoking, physical activities with at least 3 times a week and 30 min per time, BMI<25 Kg/M2.
  • Cost-effectiveness rate of Endothelial Function Testing [ Time Frame: up to 54 months ]
    The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • Improvement [ Time Frame: up to 30 months ]
    The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
  • Incidence [ Time Frame: up to 30 months ]
    The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
  • Reduction [ Time Frame: up to 30 months ]
    The reduction in lipid levels from baseline to 12 months
  • Reduction [ Time Frame: up to 30 months ]
    The reduction in blood pressure from baseline to 12 months
  • Compliance [ Time Frame: up to 30 months ]
    The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.
  • Compliance [ Time Frame: up to 30 months ]
    The percentage of patients with appropriate prescription of cholesterol, blood pressure and glucose lowering medications by physicians at 3, 6 and 12 months after baseline.
  • Compliance [ Time Frame: up to 30 months ]
    The percentage of patients with healthy life style at 3, 6 and 12 months after baseline. The healthy life style is defined as having no smoking, physical activities with at least 3 times a week and 30 min per time, BMI<25 Kg/M2.
  • Cost-effectiveness [ Time Frame: up to 54 months ]
    The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease
Official Title  ICMJE Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
Brief Summary The purpose of this study is to systematically evaluate the clinical application value of vascular endothelial function examination in patients with non-obstructive coronary artery disease.
Detailed Description The study will be carried out in two stages. Phase I is mainly intended to evaluate the effects of vascular EFT on the prescription of doctors and the application rate of mid and long-term secondary prevention medication in patients. If the results are positive, the sample size and observation time will be further expanded in Phase II to evaluate its impact on the cardiovascular events of patients, as well as its cost-effectiveness.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Multicenter, randomized, patient and assessor blinded, parallel control, two-stage, clinical trial.

Phase I: a feasibility study to collect data on key process outcomes including physician's prescription behaviors, patients' cardiovascular risk, and trend of reduction in cardiovascular events, To create an initial and to inform for the Phase II larger multicenter trial on choosing clinical endpoints and sample size.

Phase II: will extend all patients from Phase I to a longer period of follow up and recruit more new patients to enlarge the sample size, in order to have a full study on the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with NOCAD.

Masking: Double (Participant, Outcomes Assessor)
Masking Description:
This study is patient and assessor blinded; that is, both groups of patients are unaware of the endothelial function results. This study will use blind methods for endpoint data collectors; that is, the data collectors will collect secondary prevention medication and cardiovascular event data for coronary artery disease without an awareness of patient grouping.
Primary Purpose: Other
Condition  ICMJE Non-obstructive Coronary Artery Disease
Intervention  ICMJE Other: Endothelial function guided therapy
To evaluate the effect of integration of non invasive endothelial function test (EFT) as a routine test in increasing appropriate treatment to reduce cardiovascular risk including prescription of lipid, blood pressure and glucose lowering medications by physicians at the clinic for patients with non-obstructive coronary artery disease (NOCAD) and the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with non-obstructive coronary artery disease(NOCAD).
Study Arms  ICMJE
  • Experimental: Intervention group
    Intervention group: Before the patient returns to the doctor and the prescription is issued, the EDCM system will feed back the EndoPAT test results to the responsible doctor through the automatically generated information on the doctor's mobile phone, but will not let the patient know the endothelium test results (blinded to the patient).
    Intervention: Other: Endothelial function guided therapy
  • No Intervention: Control group
    Control group: The EDCM system will not report the EndoPAT test results to the responsible doctor (the doctor cannot see the final EFT results), nor can the patients know the EFT results.
Publications * Hwang IC, Jeon JY, Kim Y, Kim HM, Yoon YE, Lee SP, Kim HK, Sohn DW, Sung J, Kim YJ. Association between Aspirin Therapy and Clinical Outcomes in Patients with Non-Obstructive Coronary Artery Disease: A Cohort Study. PLoS One. 2015 Jun 2;10(6):e0129584. doi: 10.1371/journal.pone.0129584. eCollection 2015.

*   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: July 7, 2019) 		1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Age: 18 years or older;
  • 2. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
  • 3. Having signed their written informed consent.

Exclusion Criteria:

  • 1. Left ventricular ejection fraction ≤ 50%;
  • 2. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
  • 3. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
  • 4. Severe nephropathy (uremia, renal failure);
  • 5. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
  • 6. Malignant tumor;
  • 7. Mental disorders or cognitive disorders;
  • 8. Participating in other interventional clinical trials;
  • 9. There are any other factors that the treating doctors think are not suitable for inclusion or completion of this study.
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: Huan LIU, MSc 15650783607 liuhuan07@bjmu.edu.cn
Contact: Yao LU, MSc 18500655509 luyao_pucri@bjmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013204
Other Study ID Numbers  ICMJE PUCRI-2019- EndoFIND-01
Has Data Monitoring Committee Yes
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: Undecided
Responsible Party Wang Hongyu, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE
  • Mayo Clinic
  • Peking University Shougang Hospital
Investigators  ICMJE
Principal Investigator: Hongyu Wang, MD Peking University
Study Director: Gaoqiang Xie, PHD Peking University
PRS Account Peking University
Verification Date March 2021

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

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