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

Overview

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.

Full Title of Study: “Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2023

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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) .

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University
  • Collaborator
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wang Hongyu, Professor, Peking University Clinical Research Institute – Peking University
  • Overall Official(s)
    • Hongyu Wang, MD, Principal Investigator, Peking University
    • Gaoqiang Xie, PHD, Study Director, Peking University
  • Overall Contact(s)
    • Huan LIU, MSc, 15650783607, liuhuan07@bjmu.edu.cn

References

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.

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