Clinical trial NCT04013204: Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease
Official title: Endothelial Function Guided Therapy in Patients With Non-obstructive Coronary Artery Disease (EndoFIND Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-obstructive Coronary Artery Disease
Keywords: non invasive endothelial function test
non-obstructive coronary artery disease
Major Adverse Cardiovascular Events
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Peking University Shougang Hospital
First posted: 2019-07-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance rate of patients to physicians prescription
timeFrame: up to 30 months
measure: Total incidence number of Major Adverse Cardiovascular Events
timeFrame: up to 54 months
Secondary outcomes:
measure: Mean improvement of endothelial function
timeFrame: up to 30 months
measure: Incidence number of Major Adverse Cardiovascular Events
timeFrame: up to 30 months
measure: Reduction of lipid levels
timeFrame: up to 30 months
measure: Reduction of blood pressure
timeFrame: up to 30 months
measure: Compliance rate of patients with treatment target
timeFrame: up to 30 months
measure: Compliance rate of patients with appropriate prescription by physicians
timeFrame: up to 30 months
measure: Compliance rate of patients with healthy life style
timeFrame: up to 30 months
measure: Cost-effectiveness rate of Endothelial Function Testing
timeFrame: up to 54 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Shougang Hospital
Study officials:
affiliation: Peking University
name: Hongyu Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University
name: Gaoqiang Xie, PHD
role: STUDY_DIRECTOR
References:
citation: 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.