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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-obstructive Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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).

Group Type EXPERIMENTAL

Endothelial function guided therapy

Intervention Type OTHER

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).

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No