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

Sponsor

Peking University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04013204

Collaborator

Mayo Clinic (Other), Peking University Shougang Hospital (Other)

1,000

Enrollment

Location

Arms

57.6

Anticipated Duration (Months)

17.4

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Aug 15, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 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.

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

Compliance rate of patients to physicians prescription [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 [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

Mean improvement of endothelial function [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 [up to 30 months]
The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months
Reduction of lipid levels [up to 30 months]
The reduction in lipid levels from baseline to 12 months
Reduction of blood pressure [up to 30 months]
The reduction in blood pressure from baseline to 12 months
Compliance rate of patients with treatment target [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 [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 [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 [up to 54 months]
The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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