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)

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.

Study Overview

• Status: Recruiting
• Conditions: Non-obstructive Coronary Artery Disease
• Intervention / Treatment: Other: Endothelial function guided therapy

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: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huan LIU, MSc; Phone Number: 15650783607; Email: liuhuan07@bjmu.edu.cn
• Study Contact Backup: Name: Yao LU, MSc; Phone Number: 18500655509; Email: luyao_pucri@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Shougang Hospital
    • Contact: Hongyu Wang, MD; Phone Number: 13910906891; Email: dr.hongyuwang@foxmail.com
    • Principal Investigator: Hongyu Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 30 months
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).	up to 54 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean improvement of endothelial function	The mean improvement in endothelial function from baseline to 12 months, estimated by RHI(Reactive Hyperemia Index).	up to 30 months
Incidence number of Major Adverse Cardiovascular Events	The incidence number of MACE(Major Adverse Cardiovascular Events) during 0 to 12 months	up to 30 months
Reduction of lipid levels	The reduction in lipid levels from baseline to 12 months	up to 30 months
Reduction of blood pressure	The reduction in blood pressure from baseline to 12 months	up to 30 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.	up to 30 months
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.	up to 30 months
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.	up to 30 months
Cost-effectiveness rate of Endothelial Function Testing	The cost-effectiveness incremental ratio of Endothelial Function Testing in reducing MACE(Major Adverse Cardiovascular Events) .	up to 54 months

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Mayo Clinic; Peking University Shougang Hospital
• Investigators: Principal Investigator: Hongyu Wang, MD, Peking University; Study Director: Gaoqiang Xie, PHD, Peking University

Publications and helpful links

General 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.

Helpful Links

• Li Zhennan, Lv Bin, Wang Zhiqiang, Liu Kun, Hou Zhihui, Gao Yang, Yin Weihua, Ren Xinshuang, Jiang Shiliang, Dai Ruping. The effect of coronary CT angiography on coronary heart disease prevention strategies. Natl Med J China, 2015;95:2664-7.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 7, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Major Adverse Cardiovascular Events; non invasive endothelial function test; non-obstructive coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: PUCRI-2019- EndoFIND-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No