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

Primary Purpose

Non-obstructive Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endothelial function guided therapy
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-obstructive Coronary Artery Disease focused on measuring non invasive endothelial function test, non-obstructive coronary artery disease, Major Adverse Cardiovascular Events

Eligibility Criteria

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

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.

Sites / Locations

  • Peking University Shougang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Compliance rate of patients to physicians prescription
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
The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).

Secondary Outcome Measures

Mean improvement of endothelial function
The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
Incidence number of Major Adverse Cardiovascular Events
The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
Reduction of lipid levels
The reduction in lipid levels from baseline to 12 months
Reduction of blood pressure
The reduction in blood pressure from baseline to 12 months
Compliance rate of patients with treatment target
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
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
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
The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .

Full Information

First Posted
July 1, 2019
Last Updated
March 10, 2021
Sponsor
Peking University
Collaborators
Mayo Clinic, Peking University Shougang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04013204
Brief Title
Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease
Acronym
EndoFIND
Official Title
Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Mayo Clinic, Peking University Shougang Hospital

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-obstructive Coronary Artery Disease
Keywords
non invasive endothelial function test, non-obstructive coronary artery disease, Major Adverse Cardiovascular Events

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Endothelial function guided therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Compliance rate of patients to physicians prescription
Description
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.
Time Frame
up to 30 months
Title
Total incidence number of Major Adverse Cardiovascular Events
Description
The incidence number of MACE(Major Adverse Cardiovascular Events) including total death, non-fatal AMI or stroke(including stroke revascularization).
Time Frame
up to 54 months
Secondary Outcome Measure Information:
Title
Mean improvement of endothelial function
Description
The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).
Time Frame
up to 30 months
Title
Incidence number of Major Adverse Cardiovascular Events
Description
The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
Time Frame
up to 30 months
Title
Reduction of lipid levels
Description
The reduction in lipid levels from baseline to 12 months
Time Frame
up to 30 months
Title
Reduction of blood pressure
Description
The reduction in blood pressure from baseline to 12 months
Time Frame
up to 30 months
Title
Compliance rate of patients with treatment target
Description
The percentage of patients with treatment target attained in terms of hypertension, diabetes, and dyslipidemia at 12 months after baseline.
Time Frame
up to 30 months
Title
Compliance rate of patients with appropriate prescription by physicians
Description
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.
Time Frame
up to 30 months
Title
Compliance rate of patients with healthy life style
Description
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.
Time Frame
up to 30 months
Title
Cost-effectiveness rate of Endothelial Function Testing
Description
The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .
Time Frame
up to 54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huan LIU, MSc
Phone
15650783607
Email
liuhuan07@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yao LU, MSc
Phone
18500655509
Email
luyao_pucri@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyu Wang, MD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaoqiang Xie, PHD
Organizational Affiliation
Peking University
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Shougang Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Wang, MD
Phone
13910906891
Email
dr.hongyuwang@foxmail.com
First Name & Middle Initial & Last Name & Degree
Hongyu Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26035823
Citation
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.
Results Reference
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Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease

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