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

NCT04013204 | Unknown DMC

• 1 other identifier: PUCRI-2019- EndoFIND-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-obstructive Coronary Artery Disease

Keywords

non invasive endothelial function test; non-obstructive coronary artery disease; Major Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Mean improvement of endothelial function

  up to 30 months

• Incidence number of Major Adverse Cardiovascular Events

  up to 30 months

• Reduction of lipid levels

  up to 30 months

• Reduction of blood pressure

  up to 30 months

• Compliance rate of patients with treatment target

  up to 30 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Endothelial function guided therapy 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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 years or older;
• \. Patients with NOCAD defined by CT or CAG results of less than 50% occlusion;
• \. Having signed their written informed consent.

You may not qualify if:

• \. Left ventricular ejection fraction ≤ 50%;
• \. Serious endocrine diseases (severe hyperthyroidism, hypothyroidism);
• \. Severe liver diseases (jaundice hepatitis, liver cirrhosis, liver failure);
• \. Severe nephropathy (uremia, renal failure);
• \. Severe inflammatory diseases (severe infection, lupus erythematosus, etc.);
• \. Malignant tumor;
• \. Mental disorders or cognitive disorders;
• \. Participating in other interventional clinical trials;

Sponsors & Collaborators

• Peking University: lead
• Mayo Clinic: collaborator
• Peking University Shougang Hospital: collaborator

Study Sites (1)

Peking University Shougang Hospital

Beijing, China

RECRUITING

Related 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.

  PMID: 26035823 BACKGROUND

Study Officials

• Hongyu Wang, MD

  Peking University

  PRINCIPAL INVESTIGATOR

• Gaoqiang Xie, PHD

  Peking University

  STUDY DIRECTOR

Central Study Contacts

Huan LIU, MSc

CONTACT

15650783607; liuhuan07@bjmu.edu.cn

Yao LU, MSc

CONTACT

18500655509; luyao_pucri@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Peking University Clinical Research Institute

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 9, 2019
• Study Start: August 15, 2019
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

CN (1)