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

Non-obstructive Coronary Artery Disease Clinical Trial

— EndoFIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04013204
• Other study ID #: PUCRI-2019- EndoFIND-01
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: June 2024

Study information

• Verified date: March 2021
• Source: Peking University
• Contact: Huan LIU, MSc
• Phone: 15650783607
• Email: liuhuan07[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Non-obstructive Coronary Artery Disease

Intervention

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).

Locations

Country	Name	City	State
China	Peking University Shougang Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University	Mayo Clinic, Peking University Shougang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Reduction of lipid levels	The reduction in lipid levels from baseline to 12 months	up to 30 months
Secondary	Reduction of blood pressure	The reduction in blood pressure from baseline to 12 months	up to 30 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External 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.